JOHN CARLOS I

KING OF SPAIN

To all who present it and understand it.

Sabed: That the General Courts have approved and I come to sanction the following law.

PREAMBLE

Law 29/2006 of 26 July on the guarantees and rational use of medicinal products and medical devices is the legal framework in which all the provisions relating, inter alia, to the assessment, authorisation, registration, manufacture, storage, distribution and monitoring of the benefit-risk ratio of medicinal products which make possible the safety, quality and efficacy of the medicinal products.

Since its adoption, there have been a number of changes in the legal configuration of the European Union taking into account the experience gained and following various evaluation actions carried out by the European Union in some of the issues related to the pharmaceutical sector, such as the pharmacovigilance of medicinal products, the strengthening of the quality of medicinal products and the protection of the supply chain in the face of the risk of counterfeit medicines; or the modifications to the marketing authorisations for medicinal products, with the object to eliminate differences in national legislation and to ensure the proper functioning of the internal market for medicinal products, as well as a high level of protection of public health and the health of persons and animals, which require our country to review the current internal regulations.

In effect, on the one hand, Directive 2010 /84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001 /83/EC on the establishment of a code of conduct for the Community on medicinal products for human use.

And on the other hand, the approval of Directive 2011 /62/EU of the European Parliament and of the Council of 8 June 2011 amending, as regards the prevention of the entry of counterfeit medicinal products into the chain, is produced of legal supply, Directive 2001 /83/EC establishing a Community code on medicinal products for human use.

These directives are to be incorporated into national legislation, through this Law to subsequently proceed with the corresponding update of your development regulations.

Thus, this law entails compliance with the need to adapt as soon as possible to the new European pharmacovigilance standards established in order to protect public health and to do so in a harmonised manner for all medicinal products for human use regardless of the authorisation procedure for medicinal products, so that it is not possible that national rules are not aligned with those of products authorised centrally by the European Commission.

In addition, this law requires an essential reinforcement of guarantees in the manufacture and distribution of medicinal products and their active substances, as well as the legal sale of medicinal products through the Internet or other telematic means. (a) indirect, and in the prevention of the entry of counterfeit medicinal products into the legal supply channel, in accordance with the relevant European legislation in force.

Consequently, this Law amends the provisions of Law 29/2006 of 26 July on pharmacovigilance (Articles 17.9, 22, 53 and 101.2.c.9.) and on falsified medicinal products (Articles 8, 64, 66 bis, 69, 71). 71 (a), 101.2.b.1. (33) and (34) and (3) and (2) (2)

In turn, during this period, Directive 2009 /53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001 /82/EC and Directive 2001 /83/EC on variations in respect of the of the terms of the marketing authorisations for medicinal products, ensuring that all of them, irrespective of the authorisation procedure, national or European, are subject to the same criteria for application, assessment and authorization.

This Directive 2009 /53/EC of the European Parliament and of the Council of 18 June 2009 was incorporated into the national legal order through Royal Decree 1091/2010 of 3 September 2010 amending the Royal Decree of the European Parliament and of the Council Decree 1345/2007 of 11 October 2007 regulating the procedure for the authorisation, registration and conditions for the supply of medicinal products for human use manufactured industrially, and Royal Decree 1246/2008 of 18 July 2008, for which the regulates the procedure for the authorisation, registration and pharmacovigilance of medicinal products Industrially manufactured veterinarians.

Therefore, in order to be consistent with the overall objective of Directive 2009 /53/EC of the European Parliament and of the Council of 18 June on the elimination of differences in national legislation, it is necessary, in turn, the adequacy of the references contained in Law 29/2006 of 26 July on the modification of marketing authorisations with the aim of simplifying, clarifying and relaxing the legislative framework in the assessment of modifications without compromising public health.

Consequently, this Law amends the provisions of Law 29/2006 of 26 July concerning amendments to the marketing authorisations (Articles 9, 15, 23, 24, 25, 31, 32 and 101.2.b.6.).

In addition, and in relation to cosmetic products, since the adoption of Law 29/2006 of 26 July, important regulatory changes have occurred, such as the adoption of Regulation (EC) No. 1272/2008, of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, which introduced certain amendments to Council Directive 76 /768/EEC of 27 July 1976 on to cosmetic products, among other things, as far as the definition of cosmetic product is concerned. In addition, Regulation 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, which also affects the definition of such products, has been published.

Consequently, the update of the definition of a cosmetic product is therefore necessary, and the definition and name of personal hygiene products by personal care products is also amended, more extensive than the previous one, and it collects, more fully, its true content.

Likewise, and for reasons of public health or safety of persons, it is necessary to extend explicitly to medical devices and to cosmetics and personal care products, according to the new denomination collected In this Law, the various provisions that the Law already collects for medicinal products through the modifications introduced in Article 4, on the guarantees of defense of public health, and in Article 99, on precautionary measures. In turn, these same reasons make it necessary to restrict the sale at home and any type of indirect sale to the public of medical devices, as well as the advertising of these products, which are regulated respectively in Articles 2 and 78 of the Law.

In another order of things, and for the sole purpose of giving greater precision to the applicable rules, the wording of Article 86 (5) and Article 94 (a) of the Law relating respectively to the substitution by the pharmacist of prescribed medications and the level of contribution of the persons surveyed in the General Mutual Mutual Society of Civil Servants of the State, the Social Institute of the Armed Forces and the Judicial Mutual General.

On the other hand, the regime of infringements and sanctions in the field of both medical devices and cosmetic products, derives from Law 14/1986 of 25 April, General of Health, which refers to the regulations specific to these subjects. Consequently, and since these specific regulations currently constitute different norms with the rank of royal decree, it is necessary to include them in this Law.

With regard to the amendment of Article 109, these are measures to promote the availability of veterinary medicinal products for species called minors, through the exemption of 70% of the rate in the the conditions for authorisation of these medicinal products to be changed, since at present there is a lack of availability of veterinary medicinal products for certain species and for certain uses. The need for these medicinal products is given both for public health reasons, since it is necessary to have medicinal products intended for these species in which the waiting times have been assessed by the competent authority in order to preserve their health. consumers of food from these species, such as for reasons of animal health and animal welfare.

For various reasons, the article 111 is also reworded, and it can highlight the different normative and organizational changes in the Spanish Agency for Medicines and Health Products produced from the entry into force of Law 29/2006 of 26 July, which has simplified certain procedures and allowed the provision of others to be defined. Therefore, and constituting the taxable fact of the fee, the provision or realization, by the Spanish Agency of Medicines and Health Products, of the services or activities referred to in Article 111 of Law 29/2006, of 26 July, it is appropriate to amend those rates qualitatively and quantitatively to adapt them to the services or activities provided.

Likewise, the operation of the Spanish Agency for Medicines and Health Products within the framework of European agencies and the existence of coordinated European procedures also becomes a reason for the modification of certain fees. Although the technical criteria with which the Spanish Agency for Medicines and Health Products evaluates the drugs are the same regardless of the procedure used, the workload is very different when the Spanish Agency of Medicines and Health Products evaluates in order to issue a national authorisation of when acting as a reference Member State assuming responsibility for the assessment of the so-called Decentralised Procedures or in the Mutual Recognition Procedures.

Finally, this Law includes a new additional provision, the fifteenth one, concerning the modification of the sense of silence, with the aim of incorporating new procedures to those already fixed by the Additional provision twenty-ninth of Law 14/2000 of 29 December, of tax, administrative and social measures, for the health impact of the administrative silence of the applications for certain Procedures in the field of application of Law 29/2006, of 26 July, could be carried out.

This Act consists of a single article, distributed in sixty-nine paragraphs, four additional provisions, a transitional provision, a derogation provision, and nine final provisions.

Single item. Amendment of Law 29/2006 of 26 July on the guarantees and rational use of medicinal products and medical devices.

Law 29/2006 of 26 July on the guarantees and rational use of medicinal products and medical devices is amended as follows:

One. A new paragraph 4 is inserted in Article 1, with the following wording:

" 4. In turn, it regulates cosmetics and personal care products and, in particular, the precautionary measures and the regime of infringements and penalties applicable to them. "

Two. Article 2 (5) is worded as follows:

" 5. The sale by correspondence and by telematic procedures of medicinal products and medical devices subject to prescription is prohibited. The implementing rules shall lay down the applicable requirements and shall regulate those arrangements for sale in respect of medicinal products which are not subject to prescription, while ensuring that medicinal products for human use are dispensed by an office. of a pharmacy authorized, with the intervention of a pharmacist, prior to personalized advice as provided for in Articles 19.4 and 84.1 of this Law, and with compliance with the applicable regulations according to the medicinal products to be sold or the mode of sale and compliance with the information requirements set out in the Law 34/2002 of 11 July on the services of the information society and electronic commerce and, in the case of veterinary medicinal products, is dispensed by one of the establishments described in paragraphs (a) and (b) of Article 38.2 of the Law, with the intervention of a pharmacist, and must also comply with the requirements laid down in Law 34/2002 of July 11.

It is also prohibited to sell at home and any type of indirect sale to the public of medicines. Health administrations may, for reasons of public health or safety, limit, condition or prohibit the sale of products to the public at home and any type of indirect sale to the public of medical devices.

The provisions of this paragraph are without prejudice to the distribution, distribution or supply to entities legally authorized to dispense with the public.

The development regulations will lay down the requirements so that they can be sold directly to medical, dental, veterinary and podiology professionals exclusively for the medicines necessary for the exercise of their professional activity. "

Three. Article 2 (6), which is worded as follows, is amended as follows:

" 6. The custody, conservation and dispensing of medicinal products for human use shall be exclusively:

a) To the legally authorized offices of pharmacy open to the public.

b) To the pharmacy services of the hospitals, health centers and primary care structures of the National Health System for their application within these institutions or for the drugs that require a particular surveillance, supervision and control of the multidisciplinary health care team, in accordance with the qualification granted by the Spanish Agency for Medicines and Health Products for such medicinal products.

(c) In the field of the National Health System, in addition to the medicinal products specified in point (b) of this paragraph, it shall correspond to the pharmacy services of the hospitals, the custody, conservation and dispensing of the medicinal products for human use in which the Ministry of Health, Social Services and Equality agrees to establish singular reserves, limiting their dispensation without the need for a visa for non-hospitalized patients.

However, in the case of clinical trials carried out in research centres which do not have pharmacy services, it is possible to send the investigational medicinal products to the research centre, The investigator of that center assumes the responsibilities regarding the correct administration, custody and delivery of these medications according to the protocol of the study.

The dispensing, sale or marketing of any drug that is returned or delivered by patients, or the general public, to pharmacy offices is prohibited. "

Four. Article 3 (2) is worded as follows:

" 2. Likewise, the professional practice of the pharmacist in the office of pharmacy, in a detailed commercial establishment, in livestock groups or groups or in a hospital pharmacy service and other care structures shall be incompatible with the any class of direct economic interests of the pharmaceutical laboratories and/or wholesale warehouses. '

Five. In Article 4, the current paragraph 3 becomes paragraph 4 and a new paragraph 3 is inserted, with the following wording:

" 3. The provisions laid down in the preceding paragraphs shall apply to products which are presented as medical devices or as cosmetic products without such consideration, as well as to medical devices and cosmetic products which are market without having followed the procedures laid down in their specific regulations. "

Six. Paragraphs (c), (d), (l), (m) and (n) of Article 8 are amended as follows:

"(c)" active substance or active substance " means any substance or mixture of substances intended for the manufacture of a medicinal product and which, when used in its production, are converted into an active component of that medicinal product intended to exercise pharmacological, immunological or metabolic action in order to restore, correct or modify physiological functions, or to establish a diagnosis.

(d) "Excipient" means any component of a medicinal product other than the active substance and conditioning material.

(l) "Health product" means any instrument, device, equipment, software, material or other article, used alone or in combination, including software intended by its manufacturer for purposes specific diagnosis and/or therapy and which are involved in their proper functioning, intended by the manufacturer to be used in human beings for the purpose of:

1. º diagnosis, prevention, control, treatment, or relief of a disease,

2. º diagnosis, control, treatment, relief, or compensation for an injury or deficiency,

3. research, replacement or modification of the anatomy or a physiological process,

4. Regulation of conception,

and do not exercise the main action that you want to obtain inside or on the surface of the human body by pharmacological, immunological or metabolic means, but whose role such media can contribute.

m) "Personal care product" means substances or mixtures which, without the legal consideration of medicinal products, medical devices, cosmetics or biocidal products, are intended to be applied on the skin, teeth or mucous membranes of the body human for the purpose of hygiene or aesthetics, or to neutralize or remove ectoparasites.

n) "cosmetic product" means any substance or mixture intended to be brought into contact with the surface parts of the human body (epidermis, hair and hair system, nails, lips and external genital organs) or with teeth and Mouth mucous membranes, for the sole or sole purpose of cleaning, perfuming, modifying their appearance, protecting them, keeping them in good condition or correcting body odours. "

Seven. Four new paragraphs (o), (p), (q) and (r) are added to Article 8, with the following wording:

"(o)" falsified medicinal product " means any medicinal product whose presentation is false with respect to:

1. the identity, including the packaging and labelling, the name or composition in respect of any of its components, including the excipients, and the dosage of such components;

2. the origin, including the manufacturer, the country of manufacture, the country of origin and the marketing authorisation holder; or

3. your history, including records and documents relating to the distribution channels used.

This definition does not include inadvertent quality defects and is without prejudice to violations of intellectual property rights.

p) "Wholesale distribution of medicinal products" means any activity consisting of obtaining, storing, preserving, supplying or exporting medicinal products, excluding the supply to the public of such medicinal products.

q) "Contract Store" means an entity acting as a third party, with which a laboratory or a wholesale warehouse subscribes to a contract to perform certain drug distribution activities.

r) "Drug mediation" means all activities relating to the sale or purchase of medicinal products, with the exception of those included in the definition of wholesale distribution, as defined in this Article, which does not they include physical contact with them and that they consist of the negotiation independently and on behalf of another legal or natural person. "

Eight. Article 9 (2) is worded as follows:

" 2. When a medicinal product has obtained an authorisation, in accordance with the previous paragraph, any dosage, pharmaceutical form, route of administration and additional presentations, as well as any other modifications and extensions to the dossier of the authorization to be introduced, shall be the subject of authorization or notification, as provided for in the rules governing the procedure for the authorization, registration and conditions for the supply of medicinal products for human use manufactured industrially. All such modifications shall be considered as belonging to the same global marketing authorisation, in particular for the purposes of the application of the data exclusivity periods. '

Nine. Article 14 (2) is worded as follows:

" 2. The name of the medicinal product may consist of a name of fantasy which cannot be confused with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder.

The name of the medicinal product may not be confused with a Spanish official name or an international name or be misleading about the therapeutic properties or the nature of the medicinal product.

Generic medicinal products must be designated with a Spanish official name of active substance and, failing that, with the international name or, if not, the common name of the usual name or Scientific evidence of such a substance, accompanied, where appropriate, by the name or mark of the holder or manufacturer; may also be referred to as a trade mark provided that it cannot be confused with a Spanish official name or an international common name or Induce a mistake about the therapeutic properties or the nature of the medicine.

Those medicines to be determined by the Spanish Agency for Medicines and Health Products may be identified with the acronym EFG (Generic Pharmaceutical Equivalent) for their interchangeability. "

Ten. Article 15 (1) is worded as follows:

" 1. The Ministry of Health, Social Services and Equality shall regulate the aspects relating to information guarantees: characteristics, extent, details and places to be included. In any case, for the preparation of this information on the medicinal product, the holder shall provide sufficient written information on his identification, indications and precautions to be observed in his employment. This information shall be submitted, at least, in the official Spanish language of the State and the technical information sheet, package leaflet and the label shall be drawn up.

The texts and other characteristics of the technical information sheet, the package leaflet and the labelling form part of the authorization of the medicinal products and must be authorized by the Spanish Agency for Medicinal Products and Products. Sanitary. Their amendments shall also require prior authorisation or notification, as appropriate. '

Once. Article 17 (9) is worded as follows:

" 9. The holder of the authorization of a medicinal product must keep the file provided to obtain it, incorporating the same data, reports or technological changes as necessary for the advances of science and standards of correct manufacturing and control. It shall also provide the periodic safety update reports as set out in the legislation in force in order to keep the safety file up to date. "

Twelve. Article 22 (1) (b) shall be worded as follows:

"(b) When, based on safety data and/or efficacy, the medicinal product has an unfavourable benefit-risk ratio."

Thirteen. A new paragraph (g) is added to Article 22 (1), with the following wording:

"g) When meeting the requirements laid down in the conditions of marketing authorisation for pharmacovigilance."

Fourteen. Article 23 is worded as follows:

" Article 23. Amendments to the authorisation for reasons of general interest.

The Spanish Agency for Medicinal Products and Sanitary Products may amend, in a justified manner and by notifying the holder of the marketing authorisation, the authorisation of medicinal products which require it for reasons of public interest or defence of the health or safety of persons. This shall, without prejudice to the obligation of the marketing authorisation holder to ensure that the information in its products is up to date on the basis of the latest scientific knowledge, including the conclusions of the evaluations and the recommendations published on the European medicines web portal and on the website of the Spanish Agency for Medicines and Health Products. "

Fifteen. A new paragraph 7 is added to Article 24, with the following wording:

" 7. The Spanish Agency for Medicinal Products and Sanitary Products may establish special authorisation procedures for medicinal products which, in accordance with an express resolution of the same, are deemed necessary to meet special requirements, provided that they are intended for use by an individual patient on the prescription of an accredited practitioner and under his direct responsibility. "

Sixteen. Article 25 (2) is worded as follows:

" 2. Where a veterinary medicinal product has obtained an authorisation, in accordance with the above paragraph, any dosage, pharmaceutical form, route of administration and additional presentations, as well as any other modifications and extensions to the the authorisation file to be introduced shall be the subject of authorisation or notification as provided for in the rules governing the procedure for the authorisation, registration and pharmacovigilance of veterinary medicinal products manufactured industrially. All such modifications shall be considered as belonging to the same global marketing authorisation, in particular for the purposes of the application of the data exclusivity periods. '

seventeen. Article 31 (1) is hereby worded as follows:

" 1. The Ministries of Agriculture, Food and the Environment, Health, Social Services and Equality shall regulate the aspects relating to the guarantees of information: characteristics, extension, details and places to be included. In any case, the holder shall provide sufficient written information on the identification, indications and precautions to be taken in his employment for the purposes of drawing up this information on the veterinary medicinal product. This information shall be submitted, at least, in the official Spanish language of the State and the technical information sheet, package leaflet and the label shall be drawn up.

The texts and other characteristics of the technical information sheet, the package leaflet and the labelling form part of the authorisation of the veterinary medicinal products and must be approved by the Spanish Medicines Agency and Sanitary Products. Their amendments shall also require prior authorisation or notification, as appropriate. '

Eighteen. Article 32 (1) is worded as follows:

" 1. In accordance with the provisions of this Law, the Government shall regulate the procedure for obtaining authorization and registration in the Register of Medicinal Products, in accordance with the procedures and deadlines established by the European Union under the Community harmonisation. The Government shall also regulate, in accordance with Community rules, the procedure for the notification and authorisation of any modifications to the initial authorisation. "

nineteen. Article 38 (2) is worded as follows:

" 2. The dispensing of medicinal products to the public shall be carried out exclusively by:

(a) The legally established pharmacy offices, which in addition will be the only ones authorized for the elaboration and dispensing of official formulas and formal preparations.

(b) Authorized retail establishments, provided that they have a pharmaceutical service responsible for the custody, preservation and dispensing of these medicinal products.

(c) Authorized livestock entities or groups with a pharmaceutical service responsible for the custody, conservation and dispensing of these medicinal products for the exclusive use of their members.

The professional performance of the pharmacist shall be regulated in each of the establishments described above in points (b) and (c) as a condition and requirement to ensure effective control in the dispensing of veterinary medicinal products to the public.

However, medicinal products intended for dogs, cats, terrarium animals, household birds, aquarium fish and small rodents which do not require veterinary prescription may be distributed and sold in other countries. establishments, in the terms provided for in regulation. "

Twenty. Article 53 (3) and (4) are amended as follows:

" 3. The autonomous communities will transfer the information received to the Spanish Agency for Medicines and Health Products. "

" 4. The authorisation holders are also required to inform the competent health authorities of pharmacovigilance of the suspected adverse reactions to which they are aware and which may have been caused by the medicinal products they manufacture or on the market, in accordance with the European guidelines on Good Pharmacovigilance Practice. They shall also be required to update the product safety information on a permanent basis, to implement the pharmacovigilance plans and risk management programmes and to carry out a continuous assessment of the relationship. benefit-risk of the medicinal product, in accordance with national and European guidelines in this field. Where health authorities consider that such information on safety is of relevant interest to public health, they shall ensure public access to it. '

Twenty-one. Article 64 (2) is worded as follows:

" 2. Pharmaceutical laboratories must comply with the correct manufacturing standards published by the Ministry of Health, Social Services and Equality, in accordance with the detailed guidelines on good manufacturing practice for medicinal products. established within the Community framework.

Furthermore, manufacturers and distributors of active substances used as raw materials shall comply with the rules of correct manufacturing of active principles and good practice of distribution of principles. assets, published by the Ministry of Health, Social Services and Equality. For such purposes, the term 'manufacture of active substances used as raw materials' means the complete or partial manufacture or the importation of an active substance used as a raw material, as defined in Article 8 of this Regulation. Law, as well as the various processes of division, conditioning and presentation prior to incorporation into a medicinal product, including reconditioning and relabelling.

The pharmaceutical laboratory may only use as raw materials active principles manufactured in accordance with the rules of correct manufacturing of active and distributed principles in accordance with good principles. distribution practices of active substances. To this end, the pharmaceutical laboratory shall verify compliance by the manufacturer and the distributors of the active principles of the correct manufacturing standards and good distribution practices by means of the audits in the manufacturing and distribution facilities of the manufacturers and distributors thereof. The pharmaceutical laboratory shall verify such compliance by itself or, without prejudice to its liability in accordance with the provisions of this Law, through an entity acting on behalf of it under a contract. "

Twenty-two. In Article 64, the current paragraphs 3, 4 and 5 become paragraphs 4, 5 and 6 and a new paragraph 3 is inserted, with the following wording:

" 3. The pharmaceutical laboratory shall ensure that the excipients are suitable for use in a medicinal product by determining appropriate manufacturing practices, with a formal risk assessment carried out in accordance with the guidelines. (a) applicable in the case of the correct manufacturing of medicinal products as well as those laid down in the Community framework. '

Twenty-three. A new Article 66a is added with the following wording:

" Article 66a. Registration of manufacturers, importers or distributors of active substances.

1. The Spanish Agency for Medicinal Products and Sanitary Products shall maintain a register of manufacturers, importers or distributors of active substances, which shall include all the data to be laid down in a regulatory manner. The health authorities of the Autonomous Communities shall have access to the complete data of this register for inspection purposes. The data in this register shall be publicly accessible and shall be developed in less than one year after the publication of this Law.

2. Registration in this register is required prior to the start of the manufacturing, import or distribution activity as well as the immediate remission of any changes in the data provided that may have an impact on the quality, the safety or effectiveness of the active substances. The submitted data will also be updated annually. "

Twenty-four. Paragraph 1 is amended and a new paragraph 3 is added to Article 69 in the following terms

" 1. The wholesale distribution stores of medicinal products, as well as the stores by contract, shall be subject to prior authorization from the autonomous community where the warehouse is domiciled. However, the warehouse must communicate the performance of its activities to the health authorities of the autonomous communities where, not being domiciled, such activities are carried out.

Distribution store authorization may include contract warehouse activity. "

" 3. Without prejudice to the provisions of paragraph 1 of this Article, the warehouses of medicinal products under control or customs supervision shall be subject to prior authorisation as a warehouse for the distribution of medicinal products to be granted by the Agency. Spanish Medicines and Healthcare products. "

Twenty-five. Article 71 is amended as follows:

" Article 71. Technical director.

All distribution entities authorized in accordance with Article 69 shall have a pharmaceutical technical director whose position shall be incompatible with other activities of a health nature which involve direct interests with the manufacture or dispensing of medicinal products or which are detrimental to the proper performance of their duties.

The Government will establish the functions of the technical director. "

Twenty-six. A new Article 71a is inserted in Chapter II of Title IV, with the following wording:

" Article 71a. Intermediation in the distribution of medicinal products for human use.

1. Persons engaged in the distribution of medicinal products for human use established in Spain must register, prior to the commencement of their activity, in a register which the Spanish Agency for Medicinal Products and Health Products shall maintain for this purpose, which shall include all data to be laid down in a regulatory manner. The health authorities of the Autonomous Communities shall have access to the complete data of this register for inspection purposes. This record will be publicly accessible.

2. Persons engaged in the trading of medicinal products shall comply with the obligations arising from the rules in force as well as the specific provisions included in the good distribution practices of the medicines published by the Ministry of Health, Social Services and Equality. '

Twenty-seven. Article 77 (1) is hereby worded as

:

" Article 77. The prescription and hospital prescription.

1. The medical prescription, public or private, and the order of hospital dispensing are the documents that ensure the establishment of a treatment with medication by instruction of a doctor, a dentist or a podiatrist, in the field of their competencies respective, unique professionals with the ability to prescribe medicinal products subject to medical prescription.

Without prejudice to the foregoing, nurses shall, autonomously, indicate, use and authorize the dispensing of all medicinal products not subject to medical prescription and medical devices, by means of order of dispensation. Physiotherapists may also indicate, use and authorize, autonomously, the dispensing of medicinal products not subject to medical prescription and medical devices related to the exercise of their profession, by order of supply.

The Government will regulate the indication, use and authorization of dispensing of certain medications subject to medical prescription by nurses in the framework of the principles of comprehensive health care and for continuity. through the application of protocols and guidelines for clinical and care practice, which are jointly developed, agreed with the medical and nurse associations and validated by the Quality Agency of the National System of Health.

The Ministry of Health, Social Services and Equality, with the participation of the corresponding collegiate organizations, will demonstrate with effects throughout the State to the nurses and the physiotherapists for the actions provided for in this Article. "

Twenty-eight. The title of Article 78, as well as the first subparagraph of paragraph 2 and paragraph 3 thereof, shall be amended; the current paragraph 3 and paragraphs 4 and 5 shall be renumbered as paragraphs 5 and 6 respectively.

" Article 78. Guarantees on the advertising of medicinal products and medical devices intended for the general public.

[...]

2. The advertising of a medicinal product which is the subject of advertising to the public shall comply with the requirements laid down in paragraph 1 of this Article; for its part, advertising messages shall meet the following requirements:

[...]

3. Advertising of medicines without a prescription will not require prior administrative authorisation, although the competent health authorities will carry out the necessary checks to ensure that the advertising content complies with the rules. laws and regulations, which are applicable to them and which are in accordance with the scientific and technical conditions laid down in the marketing authorisation.

4. Health administrations may, for reasons of public health or safety, limit, condition or prohibit the advertising of medicinal products and medical devices. "

Twenty-nine. Article 78 (5) shall be amended as follows:

" 5. In the case of medical devices, the possibility of direct or indirect advertising, directed to the public in the event that a product is financed by the National Health System, is excluded. This advertising ban affects the manufacturers, distributors or marketing companies, as well as all those entities that can maintain direct contact with the patient. Also, premiums, gifts, discounts, prizes, contests, bonuses or similar are prohibited as methods linked to the promotion or sale to the public of such products. "

Thirty. Two new paragraphs 6 and 7 are added to Article 78, with the following wording:

" 6. Medical devices intended to be used or applied exclusively by healthcare professionals shall not be the subject of advertising intended for the public.

7. The advertising of medical or surgical techniques or procedures linked to the use of specific medical devices shall respect the criteria laid down in the advertising of medical devices. '

Thirty-one. Article 85a (1) shall be read as

:

" 85a. Information systems for prescription support.

1. The competent bodies of the autonomous communities shall provide their prescribers with a common and interoperable electronic prescription system and allow the registration of the training on the number of doses adjusted to the needs of the treatment, in which prescription support subsystems such as: online drug nomenclator; correspondence between active substances, available medicines and pathologies in which they are indicated; recommended treatment for pathology from health institutions and medical societies, with an indication of the standard of choice and expected benefits; cost of the prescribed treatment and therapeutic choice alternatives, according to efficiency criteria; database of interactions; database of clinical trials in its Province or Autonomous Community; regular online information (authorisation and withdrawal of medicinal products and medical devices, alerts and communications of interest for the protection of public health); dissemination of news on medicinal products which, without be alert in the strict sense, contribute to improving the health of the population. "

Thirty-two. Article 86 (5) is worded as follows:

" 5. Where the prescription is made by trade name, if the prescribed medicinal product has a higher price than the lower price of its homogeneous group, the pharmacist shall replace the prescribed medicinal product with the lowest price of the product in his/her group. uniform, and, in the case of equality, dispense the generic medicinal product.

In the case of biosimilar medicinal products, the rules in force shall be respected in accordance with specific rules on substitution and interchangeability. "

Thirty-three. Article 87 (1) is amended and paragraph 5 is added by passing the current paragraph to be renumbered as paragraph 6, as follows:

" 1. In order to achieve adequate market supply and to provide security guarantees for citizens, laboratories, wholesale warehouses, pharmacy offices, retail establishments and institutions, or Livestock groups authorised for the supply of veterinary medicinal products are subject to the reporting obligations referred to in this Article.

[...]

5. The offices of pharmacy, retail establishments and livestock organizations or groups authorized to dispense veterinary medicinal products shall, in accordance with the terms to be laid down in regulation, communicate to the Spanish Agency Medicines and Sanitary Products the units of veterinary medicinal products dispensed.

6. The collection and processing of data referred to in this article must be in accordance with the current regulations regarding the security and protection of personal data, in compliance with the Organic Law 15/1999, of December 13, (...). "

Thirty-four. A new paragraph is added to Article 88.1, with the following wording:

" Measures to rationalise the prescription and use of medicinal products and medical devices which can be adopted by the autonomous communities will not result in differences in the conditions for access to medicinal products and Health products financed by the National Health System, catalogue and prices. Such rationalisation measures shall be homogeneous for the entire Spanish territory and shall not lead to distortions in the single market for medicinal products and medical devices. '

Thirty-five. Three new paragraphs are added to Article 88, and the current paragraph 2 is renumbered as paragraph 5 with the following wording:

" 2. The regulations of the Government or the Ministry of Health, Social Services and Equality and the resolutions issued by the competent management centre of the Ministry of Health, on the financing of medicinal products and medical devices National Health System shall take effect throughout the Spanish territory from the date on which they are applicable.

3. The industrial price of public financing, established by the competent authority of the Ministry of Health, Social Services and Equality, for medicinal products dispensed in pharmacy offices by means of an official medical prescription from the National System of Health, may not be subject to modification or bonus, except where the same consists of a percentage or linear discount applicable throughout the national territory.

The forecasts contained in the previous paragraph will also apply to medical devices, once the system of financing of prices and margins of such products, which is included in the pharmaceutical provision of the National Health System.

4. Any modification of the price of a medicine or health product financed by the National Health System will take effect on the same date throughout the Spanish territory.

5. The Interterritorial Council of the National Health System may agree on the general conditions for the planning, coordination, procurement, procurement and supply of medicines and medical devices for the ownership structures and services. public integrated into the National Health System. "

Thirty-six. A paragraph 7 is added to Article 89 with the following wording:

" 7. The procedure of incorporation into the pharmaceutical provision of the National Health System of medicinal products which, as provided for in Article 14 of this Law, will be carried out by the acronym EFG, will be regulated. interchangeability. "

Thirty-seven. Article 90 (6) is worded as follows:

" 6. As a general rule, the financing price for the National Health System will be lower than the industrial price of the drug applied when it is dispensed outside the National Health System. Pharmaceutical laboratories, wholesale warehouses and pharmacy offices through the Collegial Pharmaceutical Organization must provide the information to be determined to make the reimbursement effective due to the pharmacy offices. pharmaceutical laboratories and wholesale stores in those medicines that are established and that have been dispensed outside the National Health System. The procedure for their articulation shall be developed regulatively. "

Thirty-eight. Article 93 (2) is worded as follows:

" 2. The assemblies shall include all the presentations of medicinal products financed which have the same active substance and the same route of administration, including in the pharmaceutical supply of the National Health System, at least one presentation of a generic or biosimilar medicinal product, unless the medicinal product or its main active ingredient has been authorised at least ten years in advance in a Member State of the European Union, in which case the the existence of a generic or biosimilar medicinal product to establish a set. The presentations indicated for treatments in pediatrics, as well as those for medicinal products in the hospital, including clinical packaging, shall constitute separate sets. '

Thirty-nine. Article 94.a (9) is read as

:

" 9. The level of contribution of the persons surveyed in the General Mutuality of Civil Servants of the State, the Social Institute of the Armed Forces and the General Judicial Mutuality will be 30 percent in general, resulting from the application of the provisions of paragraph 6 (a) and subparagraph (e) of paragraph 8. '

Forty. A paragraph 2 is added to Article 95 and the current text is numera 1, with the following wording:

" 1. In the field of the National Health System, it is up to the public health authorities to evaluate the prescriptions for areas, zones, therapies, population groups, and other circumstances.

2. The Ministry of Health, Social Services and Equality shall establish coordination mechanisms to enable the use of medicinal products and medical devices to be used, to optimise research into their development and to take the necessary information and the promotion of the rational use of medicinal products and medical devices and, where appropriate, the precautionary and control measures corresponding to the requirement of administrative and criminal responsibilities to be carried out.

3. In order to implement the actions necessary for the assessment of the prescription and of the general pharmaceutical policy, the competent public authorities shall provide the aggregated or disaggregated information concerning the consumption of medicinal products. by prescription and at the level of hospital facilities and any other areas within the pharmaceutical provision of the National Health System. At least, this information will be presented on a monthly basis; it will be provided from the Ministry of Health, Social Services and Equality, which will carry out the aggregation and treatment of the before making it public. "

Forty-one. A paragraph 3 is added to Article 97, with the following wording:

" 3. The information referred to in this Article shall be provided on a monthly basis and shall be for a period not exceeding three months immediately prior to the date on which it is provided. '

Forty-two. Article 99 (1) (b) shall be read as follows:

"(b) Suspension of the preparation, prescribing, dispensing and supply of investigational medicinal products and medical devices."

Forty-three. In Article 99 (1), a new subparagraph (c) is inserted with the following wording:

" (c) The limitation, prohibition, suspension or attachment to special conditions of manufacture, import, marketing, export, advertising, placing in service or use of medical devices, cosmetics or personal care products, as well as quarantine, withdrawal from the market and recovery of such products. "

Forty-four. Article 100 (1) is worded as follows:

" 1. Infringements in the field of medicinal products, medical devices, cosmetics and personal care products shall be subject to the appropriate administrative penalties, subject to the instruction of the appropriate file, without prejudice to the civil, criminal or other order responsibilities that may be present. "

Forty-five. The title and Article 101 (1) shall be worded as follows:

" Article 101. Drug violations.

1. The infringements are considered to be minor, serious and very serious in the light of the health risk criteria, the amount of the possible benefit obtained, the seriousness of the health and social change produced, the generalisation of the infringement and recidivism. "

Forty-six. The infringement numbered as 4. in paragraph 2 (a) of Article 101 (2), which is not contained, shall be deleted, passing the current content of the infringements 5. ª, 6. ª, 7. ª, 8. ª, 9. ª, 10. ª, 11. and 12. th, 5. ª, 6. ª, 7. ª. 9. ª, 10. and 11. ª.

The infringements numbered 28 and 34. in Article 101 (2) (b), which are not contained, shall also be deleted, with the current content of the infringements 29, 30, 31, 31, 32 and 33 being deleted. The second, the third, the 30th, the 31st, and the

.

Forty-seven. The infringement referred to in paragraph 2 (a) of Article 101 (2) is amended as follows:

"7. Incompliance with the requirements for the medical visit, establish the regulations of the competent health administrations in the management of the pharmaceutical provision."

Forty-eight. The infringements numbered as 1., 2. ª, 3., 6. ª, 9. ª, 15. ª, 16. ª, 17. ª., 18. ª., 23. and 29. in paragraph 2 (b) of Article 101 shall be amended as follows:

" 1. Not to be carried out in the manufacture, manufacture, import, export and distribution of medicinal products or active substances, the quality controls required in health legislation or to comply with the detailed guidelines on rules of correct manufacturing or good distribution practices established within the Community framework or to carry out manufacturing or control processes by means of non-validated procedures. '

"2. Elaborate, Manufacture, Import, Export, Dispense, or Distribute Medicinal Products by natural or legal persons who do not have the required authorization."

"3. Hinder Inspector's work by any action or omission that disturbs or delays the work."

"6." 6. Modify by the holder, without prior authorization or notification, as appropriate, any of the conditions of authorization of the medicinal product. "

" 9. Incompliance, the sponsor or investigator of a clinical trial, the obligations established for each of them in the legislation in force, where the fact of the criteria referred to in this article does not merit the rating of very serious. "

"15. Refuse to dispense medication without justified cause."

"16. Dispense Medication without a prescription, when it is required."

"17. To supply, acquire or sell medicinal products to entities that are not authorized to carry out such activities."

" 18. Act, the health professionals involved in the cycle of prescription, dispensing and administration, and provided that they are in exercise, in the functions of medical visit delegates, representatives, agents or agents reporting of drug laboratories. "

"23. Dispense Medications in establishments other than authorized ones."

"29." 29. Accept, healthcare professionals, on the occasion of the prescription, dispensing and administration of medicines from the National Health System, or their relatives and persons from their coexistence, any type of incentives, bonuses, prohibited discounts, premiums or gifts made by those who have direct or indirect interests in the production, manufacture and marketing of medicinal products. "

Forty-nine. Five new infringements are added numbered 33, 34, 34, 35, 36, 36 and 37. in the second subparagraph of Article 101 (2) (b), with the following wording:

" 33. Incompliance, persons engaged in medication intermediation, requirements established in current regulations, and good drug distribution practices.

34. Incompliance, the manufacturer of the medicinal products, the obligations on excipients used in the manufacture of medicinal products.

35. Perform, by the holder of the laboratory authorization or the holder of a distribution authorization, activities that do not conform to it.

36. Incompliance, pharmacy offices and pharmacy services, legally established in the field of user input in the pharmaceutical provision of the National Health System.

37. Any act of the pharmacy office that induces the user to acquire a greater amount of medication within the pharmaceutical delivery of the National Health System than the truly necessary or demanded by this last. "

Fifty. The infringements numbered as 1., 2. ª, 9. ª, 11. 16, 23. and 24. in paragraph 2 (c) of Article 101 shall be drawn up in the following terms:

"1. Place medicines of any kind on the market without having obtained the prescriptive health authorization for this."

" 2. Manufacture, Import, Export, Broker, Distribute, Dispense, and Sell Counterfeit Drugs. This infringement will also apply in the event that this sale is carried out at a distance. "

"9. Incompliance, the sponsor or investigator of a clinical trial, the obligations established for each of them in the legislation in force when it is detrimental to the rights, safety and welfare of the subjects."

"11. Vender drugs at home or through the Internet or other telematic or indirect means, contrary to what is provided for in this Law or in violation of the provisions that regulate such mode of sale."

"16." 16. Conduct promotion, information or advertising of unauthorised medicinal products or without such activities being in accordance with the provisions of this Law or the general legislation on advertising. "

" 23. To carry out, on the part of the offices of pharmacy, activities of distribution of medicinal products to other offices of pharmacy, authorized wholesale warehouses, or other entities, centers or natural persons without authorization for the distribution activity or the carrying out of consignments of medicinal products outside the national territory. '

"24." 24. Disthink, sell or market the medicines returned or delivered by patients or the general public to the pharmacy offices. "

Fifty-one. Two new infringements are added numbered 25 and 26, in the second subparagraph of Article 101 (2) (c), with the following wording:

" 25. Incompliance, the holder of the marketing authorization, its obligation to have sufficiently supplied the market, in an appropriate and continuous way to enable the compliance of the requirements legally established in the field of pharmaceutical provision of the National Health System and guarantee the supply to the offices of pharmacy and pharmacy services of the medicines included in homogeneous groupings, of lower price and price less.

26. Masking for the performance of duly accredited inspectors, in the centres where medicinal products are manufactured, manufactured, distributed and dispensed. "

Fifty-two. A new paragraph 3 is added to Article 101 with the following wording:

" 3. The commission of an infringement, preceded by two or more of a degree immediately below or equal to a final penalty within one year before that commission, shall increase from a minor to serious, or from serious to very serious, such an infringement. '

Fifty-three. A new Article 101a is added with the following wording:

" Article 101a. Breaches of medical devices.

1. The infringements are considered to be minor, serious and very serious in the light of the health risk criteria, the amount of the possible benefit obtained, the seriousness of the health and social change produced, the generalisation of the infringement and recidivism.

2. They shall constitute administrative offences and shall be sanctioned in accordance with the terms of Article 102 of the following conduct:

a) Mild infractions:

1. No contributing, the entities or persons responsible, the data, statements, as well as any information that they are required to supply for health, technical, economic, administrative and financial reasons.

2. Incompliance with the duty to collaborate with health authorities in the assessment, surveillance and control of medical devices.

3. ª hinder the inspector's work by any action or omission that disturbs or delays the work.

4. To present at fairs, exhibitions and demonstrations products unfit for placing on the market or in service without the corresponding indication of their non-conformity or inability to put into service.

5. Do not keep the intended declaration for custom products at the disposal of the patient, do not inform the patient about it or not give it to them.

6. Unidentify as such products intended exclusively for export.

7. Incompliance with the requirements, obligations or prohibitions laid down in the applicable regulations which, on the basis of the criteria referred to in this Article, merit the rating of minor or where their qualification does not apply as serious or very serious faults.

b) Serious infractions:

1. Do not make it easier for the patient and/or not to include in his/her medical history the required information about the product he/she has received or the implantation card when it has been established, as well as not referring the card to the patient. the supplying undertaking or the national register which has been disposed of.

2. To manufacture, group and sterilize the products in national territory without the prior health license of the installation, as well as to import sanitary products without the prior authorization of establishment.

3. To manufacture, group, sterilize or import products without respecting the requirements or without complying with the conditions under which the operating license was granted.

4. Incompliance of the technical officer with the obligations of his or her position.

5. To market non-CE marked medical devices where this is mandatory, to use any other marking which may lead to confusion with the CE marking, and to affix the CE marking to products under conditions other than those established, except as provided for in point (c) of point (c) of this paragraph.

6. Not to keep at the disposal of the competent authorities and for the time indicated the required documentation, as well as to refuse to provide such documentation to the health authorities.

7. Infulfill the duty of marketing communication in the products in which such communication is required, as well as not to communicate the modifications produced or the cessation of the marketing.

8. Incompliance with the duty of communication of those responsible established in Spain when such communication is required as well as not communicating the modifications produced.

9. Incompliance with the manufacturer, authorised representative, importer or distributor of the obligations relating to the identification of the agents preceding or following them in the marketing chain.

10. Incompliance of the importer or the distributor with the obligations incumbent upon them to ensure that the products have followed the corresponding conformity assessment procedures and the documentation has been prepared mandatory.

11. Distribute or sell products on an outpatient basis or in establishments that have not been properly communicated or authorized, or who do not have the appropriate qualified professional or professional.

12. ª Distribute, install, maintain and use products without observing the required conditions, as well as put on sale altered sanitary products, in poor conditions or when the validity period has been exceeded.

13. Distribute implantable products without providing the corresponding implantation card when it is mandatory, as well as not giving the treatment due to such cards.

14. Vender to the public health products in cases not permitted, as well as without requiring the corresponding prescription when it is required, except as provided for in the infringement 7. of point (c) of this paragraph.

15. Conduct clinical investigations without complying with the intended procedures and conditions except as provided for in violations 8. and 9. of point (c) of this paragraph.

16. Incorrectly Execute the notified body of the actions that are entrusted to it without having any impact on the safety of the certified products.

17. Refusal to provide the notified body with the documentation requested by the Ministry of Health, Social Services and Equality to verify compliance with its requirements and obligations.

18. Incompliance of the manufacturer, authorized representative, importer or distributor the duty of notification of adverse incidents and safety actions to the Health Products Surveillance System, as well as to refuse to modify or suspend actions under the conditions required by the health authority.

19. Infulfill the duty of notification in the course of clinical investigations of the required circumstances.

20. To prevent the performance of duly accredited inspectors in the centres where they are manufactured, stored, distributed, sold or used.

21. The violation of the principle of confidentiality in relation to the information of patients and products by whom they are obliged to maintain it.

22. Put into service in Spain products that do not include in the labelling and instructions for use the required data and information, at least in Spanish.

23. Incompliance with the requirements and conditions relating to the advertising and promotion of medical devices.

24. To effect advertising directed to the public of products in which it is not permitted, except as provided for in point (c) of paragraph 12 of this paragraph.

25. To offer, grant or promise premiums, pecuniary advantages or benefits in kind to healthcare professionals or any other qualified, related to the use or prescription of medical devices, as well as to their relatives and people of their coexistence. Also requesting or accepting them.

26. Use a professional product under conditions and for uses other than those indicated by the manufacturer, or by non-qualified or duly trained personnel.

27. Use in patients who have not satisfied the conformity assessment procedures that apply to them.

28. Refuse to dispense sanitary products without justified cause.

29. Act, health professionals involved in the cycle of prescription, dispensing and administration, and whenever they are in exercise, acting as a medical visit delegate, representatives, agents or agents reporting by the health product laboratories.

30. Manufacture Tailored Sanitary Products without the corresponding prescription written by an optional.

31. Incompliance with the health care professional with the duty to report adverse incidents to the Health Products Surveillance System.

32. Incompliance, pharmacy offices and pharmacy services, legally established in the field of user input in the pharmaceutical provision of the National Health System.

c) Very severe infractions:

1. Place on the market and/or in service products that do not meet the essential requirements that apply to them.

2. Place on the market and/or in service products which have not satisfied the conformity assessment procedures or which have not made the declarations which, if necessary, result from them being applied.

3. Third Marketers and/or put into service products that compromise the health or safety of patients, users or, where appropriate, third parties.

4. Install and/or maintain inadequately products, in such a way as to compromise the health or safety of patients, users or, where appropriate, third parties.

5. Improperly Use "CE" marking on non-compliant products or have not satisfied the corresponding conformity assessment procedures, as well as products that do not have the product condition health.

6. Incompliance with the obligation to implement the measures and actions necessary to reduce or eliminate health risks caused by the products, as well as measures and actions ordered by the health authorities.

7. Vender to the public products for genetic diagnosis.

8. Conduct clinical investigations in breach of the obligations laid down in the legislation in force, when it is detrimental to the rights, safety and well-being of patients.

9. Conduct clinical investigations without having the consent of the subject of the same or, where appropriate, of his representative, or failure of the investigator to comply with the duty of information on the clinical investigation to whom participates as the subject of the same.

10. Use by a professional product under conditions and for uses other than those indicated by the manufacturer, or by non-qualified or duly trained personnel, with a risk to the health and safety of persons.

11. Run incorrectly, the notified body, the actions entrusted to it, when the safety of the certified products is impaired, as well as continue to certify the corresponding withdrawal designation.

12. To effect advertising directed to the public of the products for genetic diagnosis.

13. Falsify sanitary products, as well as falsify the accrediting documents of conformity.

14. Incompliance, the supplying company, its obligation to have sufficient supply of the market, in an appropriate and continuous manner to enable compliance with the legally established requirements of the supply with health products from the National Health System and ensure supply.

15. Any act of the pharmacy office that induces the user to acquire a greater quantity of medical devices within the pharmaceutical delivery of the National Health System than the truly necessary or demanded by the latter. "

Fifty-four. A new article 101 ter is added with the following wording:

" Article 101 ter. Breaches of cosmetic products and personal care products.

1. The infringements are considered to be minor, serious and very serious in the light of the health risk criteria, the amount of the possible benefit obtained, the seriousness of the health and social change produced, the generalisation of the infringement and recidivism.

2. They shall constitute administrative offences and shall be sanctioned in accordance with the terms of Article 102 of the following conduct:

a) Mild infractions:

1. Make it difficult for the inspector to work through any action or omission that disturbs or delays the work.

2. Incompliance with the duty to collaborate with the competent health authorities in the assessment, monitoring and control of cosmetics.

3. Incompliance with the requirements, obligations or prohibitions laid down in the applicable regulations, where, in accordance with the criteria referred to in this Article, such non-compliances deserve to be classified as minor or not rating as severe or very severe.

b) Serious infractions:

1. Merchandise as if they were cosmetic products that do not conform to the definition of such established in the current regulations, either by the place of application to which it is intended, or by its purpose.

2. To be marketed as if they were cosmetic products intended for the prevention, diagnosis and treatment of diseases, as well as those destined to be ingested, inhaled, injected or implanted in the human body or the protection against contamination or infection by micro-organisms, fungi or parasites.

3. To market substances or mixtures that are presented as cosmetics without complying with the applicable regulations.

4. Do not provide the competent authority with the information required to supply the person responsible, as well as the lack of communication of any modification of the initial information necessary communicate.

5. Do not provide the competent health authorities with the information required on the substances in which there is doubt in relation to their safety, as well as any other information required by them. authorities for the purpose of market control.

6. The lack of matching between the required mentions of product labeling and the information provided to the competent administration.

7. Merchant Cosmetics that omit on the label any of the required mentions or do not express it in the language and/or in the established terms.

8. Use on the labelling, marketing or advertising of cosmetic products texts, denominations, brands, images or any other figurative symbol or not, in order to attribute to these products features or functions they lack, as well as making claims that fail to meet the established common criteria.

9. To market cosmetic products that lead to confusion with food, medicines, medical devices, biocides or other products, or refer to the treatment of pathologies.

10. Marketed Cosmetics without having performed the safety assessment provided for in the regulation or without having performed it under the conditions laid down.

11. To carry out the activities of manufacturing cosmetic products or any of their phases, such as the control, packaging or labelling, in national territory, or of imports of cosmetics from non-Community countries without a responsible technician with appropriate qualifications in accordance with the specific regulations.

12. Manufacture Or Import Cosmetic Products, or move, extend or modify substantially the activities and facilities without having presented the responsible declaration of compliance with the requirements to perform such activities.

13. Manufacture Or Import Cosmetic Products without complying with the conditions stated in the responsible declaration, as well as the production of cosmetic products without observing the principles of good manufacturing practice.

14. Incompliance with the responsible technician and other personnel with the obligations to their positions.

15. Incompliance with the person responsible or the distributor with the obligations incumbent upon him to bring the non-compliant products into conformity and refuse to implement the measures given by the competent health authorities with this end.

16. Incompliance with the person responsible or the distributor with the obligations relating to the identification of the agents preceding or following them in the marketing chain.

17. Incompliance with the responsible person, or the distributor, the obligations incumbent upon them to ensure that the products they place on the market meet the requirements laid down in the regulations.

18. Incompliance with the duty to notify the responsible person or distributor to the health authorities of the serious undesirable effects, the risks presented by the products and the corrective measures taken.

19. To prevent the performance of duly accredited inspectors in the centres where they are manufactured, stored, distributed, sold or used for cosmetic products.

20. To supply cosmetic consumers intended for internal studies or intended to be presented at fairs, exhibitions or demonstrations and whose introduction into Spanish territory has been exclusively authorised for such purposes. end.

21. Distribute Cosmetics without observing the required conditions, as well as put on sale altered cosmetic products, in poor conditions or when the minimum duration date has been exceeded, where applicable.

22. Do not keep at the disposal of the competent health authorities any of the information that is set out in the product information file, or not to express them in Spanish, when it is required.

23. No to the public by the person responsible for the information that is required according to the regulation.

24. To introduce into the market cosmetic products manufactured in installations that have not been the subject of a responsible declaration.

c) Very severe infractions:

1. Trade in cosmetic products or products which are presented as cosmetics which damage human health when applied under normal or reasonably foreseeable conditions of use, or where the products are not consumers of the risks likely to arise from their normal use by means of instructions, warnings and appropriate indications.

2. Merchant cosmetic products that include:

1. No prohibited substances for use in cosmetics.

2. º substances in higher concentrations and/or under conditions other than those established for use in cosmetics.

3. ° Colorants, preservatives or ultraviolet filters other than those authorised for use in cosmetics, or in higher concentrations and/or under conditions other than those established.

4. º substances classified as carcinogenic, mutagenic or toxic to reproduction, outside the conditions laid down in the cosmetics regulations.

3. Marketed Cosmetics that do not meet the established requirements for animal testing.

4. ª Falsify the information to be provided to the health authority, as well as to distort the responsible declaration of compliance with requirements for the performance of manufacturing and import activities.

5. Incompliance with the duty to implement the measures and actions necessary to eliminate health risks caused by cosmetics, as well as measures and actions ordered by the health authorities.

6. To develop cosmetic products in poor technical-sanitary conditions that affect their safety.

7. Manufacture Counterfeit products, enter the market or market counterfeit products.

3. The provisions of the foregoing paragraphs shall apply to personal care products where the object of the infringement is applicable to such products.

Very serious violations will be considered in any case:

a) Markup personal care products without the prescriptive health authorization.

b) Develop personal care products in poor technical-sanitary conditions that affect their safety.

(c) to trade personal care products that harm human health when applied under normal or reasonably foreseeable conditions of use, or where consumers are not advised of the risks that they may have; they may be derived from their normal use by means of instructions, warnings and appropriate indications.

4. The commission of an infringement, preceded by two or more of a degree immediately lower or equal committed and signed within one year before that commission, shall increase from a minor to serious, or from serious to very serious, such an infringement. '

Fifty-five. A new paragraph 3 is added to Article 102, with the following wording, passing the current content of paragraphs 3, 4 and 5 to paragraphs 4, 5 and 6:

" 3. Without prejudice to the fine to be imposed in accordance with the provisions of paragraph 1 of this Article, the very serious infringement of medicinal products, as referred to in Article 101 (2) (c) (c), may lead to the disablement of the pharmacy office involved in dispensing prescriptions from the National Health System for a minimum period of 3 months and a maximum of 1 year. "

Fifty-six. A new paragraph 7 is added to Article 102 with the following wording:

" 7. The provisions of the above paragraphs shall apply to infringements in the field of medical devices and cosmetics, in accordance with Articles 101a and 1010b.

However, in the case of infringements in the field of medical devices and cosmetics, the sanction shall only be imposed to the maximum extent where the infringing action has resulted in direct or serious harm and direct to public health. "

Fifty-seven. Article 107 (1) is amended, which is worded as follows:

" 1. The fee for the provision of services and the carrying out of activities of the General Administration of the State in the field of medicinal products, medical devices, cosmetic products and personal care products is hereby established. '

Fifty-eight. Article 109 (3) is amended and two new paragraphs are added to it, numbered 6 and 7, with the following wording:

" 3. Services and activities relating to advanced therapy medicinal products which must be carried out by entities of a public nature integrated into the National Health System as well as those which have to be carried out by public bodies shall be exempt from the payment of the fee. are not intended for the placing on the market of such products. '

" 6. For veterinary medicinal products intended exclusively for minor species or minor uses, an exemption of 70% of the fees for marketing authorisations shall apply to line extensions to minor species or uses. (i) minor of medicinal products already authorised to major species, modifications to the marketing authorization, scientific advice, products in the veterinary clinical research phase, veterinary clinical trials, renewal of the authorisation, presentation of the simple annual declaration of intent of marketing and periodic safety reports, of veterinary medicinal products authorised by national procedure, of mutual or decentralised recognition. It shall not apply to the procedures for the transmission of ownership and/or representative of the holder.

7. Scientific advice on medicinal products containing only questions relating to paediatric development shall be partially exempt from the payment of the fee. The fee will be reduced by ninety-five percent of the amount set in each case. "

Fifty-nine. Article 111 is amended and is worded as follows:

" Article 111. Amount.

1. The amount of each euro fee shall be:

Group I. Medicinal Products for Human Use

Epiphon

Description	Euros
Assessment, Authorization, and Enrollment of New
1.1	Rate for Evaluation, Authorization, and Enrollment in the register of a new medicinal product for human use (an authorisation dossier submitted according to the Article 17, except as contemplated in 17.3)	20.529.17
1.2	Rate for assessment, authorisation and registration of a new medicinal product for generic human use (an authorisation file presented in accordance with Article 17.3	8.350.71
1.3	Rate for evaluation, authorization, and registration of a new medicinal gas	8.350.71
Transmission of ownership of a medicinal product for human use
1.4	Rate by the transmission procedure of the entitlement of authorization of a human use drug, or by modification of the holder representative	697.57
	Evaluation, authorization, and enrollment in the recording of a variation of a human-use drug
1.5	Rate by the procedure for modifying the authorization of a human-use drug, qualified as "major" Type II	7.051.73
1.6	Rate by the procedure for modifying the authorization of a human-use drug, qualified as Type IB	1.7
	1.7	1.7	Rate by the procedure for modifying the authorization of a human-use drug, qualified type IA (including immediate notification AI type)	717.25
Marketing authorization refresh
1.8	Rate by the procedure for renewing the authorization of a human medicinal product	2.319.51
maintenance rate authorized
1.9	Simple Annual Rate of an Already Authorized Human Use Drug	370.00
Rates parallel
1.10	Rate by the authorization procedure for the "parallel import" of a human-use drug	896.49
1.11	Rate by the authorization modification procedure for the "parallel import" of a human use drug	362.86
1.12	Rate by the authorization renewal procedure for the "parallel import" of a human use drug	362.86
1.13	355.49
	Rates By Import Notification	batch release of vaccines, blood products and bulk
	Rate by issue of a European batch release certificate for vaccines and blood products for human use when the analysis of a batch drug	1,200,00
	Rate for batch release of blood products and vaccines in accordance with Articles 41.4 and 43.3 of Royal Decree 1345/2007 of 11 October 2007:
	(a) each individualized request
	(b) between 6 and 10 requests/year (per year)	500,00
	(c) between 11 and 40 requests/year (per year)	1.500.00
	(d) between 41 and 160 requests/year (per year)	3.500.00
	(e) by more than 160 requests/year (per year)	5,000.00
1.16	Rate for the European certificate batch release issue for human use vaccines and blood products when a bulk (bulk) analysis is required	336.00
Rate by Evaluation of Gallic
	Rate by evaluating a declaration request Galenic innovation of therapeutic interest	974.30
1.18	Export Authorizations, to Countries Intra-Community and third countries, narcotic drugs and psychotropic drugs	170.00
Other
1.19	Rate for the actions provided for in Article 111 (6)	362.86
1.20	Rate by reservation of a vacancy for acting as a Reference Member State in a decentralized or mutual recognition procedure	750.00

Group II. Allergen medicines

Epiphon

Description	Euros
Assessment, authorization, and enrollment in the registry of a new human-use allergen for diagnostic
2.1	Rate by National Procedure	852.41
Transmission of entitlement of an allergen drug for diagnostic use
2.2	Rate by the transmission procedure of the entitlement of an allergen drug authorization for diagnostic use	467.78
Evaluation, authorization, and registration of a variation of a drug allergen for diagnostic use
2.3	Rate by procedure for modifying the authorization of an allergen drug for use diagnosis, rated as "major" Type II major	497.76
2.4	Rate by procedure for the modification of the authorisation of an allergen for diagnostic use, defined as Type IB	87.32
2.5	Rate by procedure for modifying authorization a drug allergen for diagnostic use, rated AI type (including immediate notification AI type)	50.63
Procedures Refreshing the marketing
2.6	Rate for the procedure for renewing the authorization of an allergen drug for diagnostic use	304.34
Annual Authorized Allergen Drug Maintenance Rate
2.7	Single Annual Rate Of A Drug allergen for already authorized diagnostic use	370.00
Rate for bulk
2.8	Rate for granel authorization	608.68

Group III. Medicinal plant medicines

Epiphon

Description	Euros
Evaluation, authorization, and enrollment in the registry of a new traditional plant-based drug (MTP)
3.1	Rate by a National Simplified Procedure	2.165.29
, authorization, and registration of a variation of a traditional plant-based drug (MTP)
3.2	Rate by the authorization modification procedure a traditional herbal medicine (MTP)	335.62
, authorization, and enrollment in the registration of a new Plant-based human use drug for well-established
3.3	National Procedure Rate, except 3.1	8.350.71
-based drug entitlement
3.4	Rate by the transmission procedure of the entitlement of an authorization traditional herbal medicinal product (MTP) or a well-established licensed plant-based medicinal product	697.57
Assessment, authorization, and enrollment in the registration of a variation of a plant-based
3.5	Rate by the procedure for the modification of the authorisation of a medicinal product for human use on a plant basis, qualified as ' of importance Greater " Type II	1.236.85
3.6	Rate by procedure for modifying authorization to a plant-based human drug, qualified as Type IB	552,15
3.7	Rate by the procedure for the modification of the authorisation of a medicinal product for human use on a plant basis, qualified as a type IA (including the immediate notification AI type)	314.70
Procedures for Authorization marketing
	3.8	Rate by procedure of renewal of a traditional herbal medicinal product (MTP) authorization	304.34
3.9	Rate by the renewal procedure for authorization of a well-established authorized use-to-use-plant-based drug	1,507.87
Authorized Plant-Based Drug Maintenance
	Simple Annual Rate of a traditional herbal medicinal product (MTP) already authorized	3.11
3.11	Simple annual rate of a well-established use-authorized plant-based drug	370.00

Group IV. Homeopathic medicinal products for human and veterinary use

Epiphon

Description	Euros
Assessment, authorization, and enrollment in the registry of a new homeopathic drug with no approved therapeutic
Rate by a procedure National simplified
4.1
	4.2	4.2	4.2	4.2	738.47
4.3	More than six strains	923.09
, authorization, and enrollment in the record of a variation of a homeopathic drug without approved therapeutic
4.4	Rate by the procedure for modifying the authorization of a homeopathic drug with no approved therapeutic indication	325.75
, authorization and registration of a new homeopathic drug with approved therapeutic
4.5	National Procedure Rate	8.350.71
Transmission of entitlement of a homeopathic drug with or without approved therapeutic
4.6	Rate by the procedure for the transfer of ownership of the authorisation of a homeopathic medicinal product with or without therapeutic indication approved, or by modification of the holder's representative	697.57
, authorization and registration of a variation of a homeopathic drug with approved therapeutic
4.7	Rate by the procedure for modification of the authorization of a homeopathic medicinal product with approved therapeutic indication, qualified as "of importance" Greater " Type II	1.236.85
4.8	Rate by procedure for modifying authorization to a homeopathic medicine with approved therapeutic indication, qualified as Type IB	552.15
4.9	Rate by the procedure for modifying the authorization of a homeopathic medication with indication approved therapeutics, qualified as type IA (including immediate notification AI type)	314.70
Procedures of the marketing
	Rate by procedure of renewal of authorization of a homeopathic medicine without approved therapeutic indication	304.34
4.11	Rate by procedure of renewal of authorization of a homeopathic drug with approved therapeutic indication	1.507, 87
Homeopathic Drug Maintenance
4.12	Simple annual rate of a homeopathic medicine without indication approved therapeutic approved	90.00
4.13	Simple annual rate of a drug homoeopathic human use with approved therapeutic indication already approved	370.00

Group V. Clinical Research

Epiphon

Description	Euros
5.1	Rate by a procedure of evaluation of the first clinical trial with unauthorized drugs in a country belonging to the International Conference of Harmonization (ICH) with active principles or combinations of active principles not authorised in Spain
	5.2
	5.2	5.2
	a) Authorization of a clinical trial with an authorised medicinal product in a country belonging to the International Conference of Harmonisation (ICH), other than Spain.	400.00
	c) Authorization of a clinical trial with the characteristics indicated in 5.1 in the cases of a reiteration of the application for authorization when the result of the first request was a withdrawal or non-authorization of the test
5.3	Procedure rate:
		111.19
	b) Authorization of a clinical trial whose promoter is a researcher or group of researchers in which a Pharmacy Service is responsible for making or masking investigational drugs
5.4	Qualification procedure as a product in a clinical investigation phase of a Unauthorized veterinary medicinal product in Spain	275.42
5.5	Rate per procedure veterinary clinical trial	111.19

Group VI. Pharmaceutical Laboratories, Manufacturers, Importers or Distributors of Active Principles and other entities developing activities with medicinal products or active substances

Epiphon

Description	Euros
6.1	Pharmaceutical lab opening authorization procedure	5.857.78
6.2	Procedure for modifying an authorization for a pharmaceutical lab by minor changes to the same	325.75
6.3 a)	Procedure modification of the authorization of a pharmaceutical laboratory for major changes in the pharmaceutical laboratory when the inspection activities do not include inspection visits	3.857.78
6.3 b)	Procedure modification of the authorization of a pharmaceutical laboratory for major changes in the pharmaceutical laboratory when the inspection visits include inspection visit	5.857.78
6.4 a)	Individual inspecting acts, except in the case of a complaint or at the request of a representative user or consumer association, in the field national	4.955.42
6.4 b)	Individual inspecting acts, except in the case of a complaint or at the request of a representative user or consumer association, in third parties countries	10.800.00
6.4 c)	Individual inspecting acts in third countries, not prescriptive, at the request of the stakeholder	20,000.00
6.5	Manufacturing authorization procedure for approved drugs in other countries and not registered in Spain	6.6
	Manufacturing Authorization Procedure by Third Parties of Human Use Drugs and/or veterinarian	325.75
6.7	Procedure for authorization and/or certification of drugs stores under control or customs surveillance.	1300,00
	Resolution of authorization of plant crops that can be used for the manufacture of narcotic drugs and psychotropic drugs	600,00
6.9	Initial Enrollment, Notification of Mandatory Modifications, or Annual Update of Registration of Principled Manufacturers, Imports, or Distributors assets	800.00
6.10	Enrollment in the registry of persons engaged in brokering in the distribution of medicinal products for human use	250.00

Group VII. Certifications and Reports

Epiphon

Description	Euros
7.1	Rate by issue of a certification	140.46
7.2	Rate for scientific advice for medicines that include questions multidisciplinary on (a) quality, safety and clinical development, or (b) quality and clinical development, or (c) safety and clinical development, or (d) pre-referral advice from a dossier	4,182.56
7.3	Rate for scientific advice for drugs that include questions about (a) clinical development, or (b) quality and safety, or (c) quality and bioequivalence studies in the case of generic drugs	3.031, 13
	7.4	Rate for scientific advice for drugs that include questions about (a) quality, or (b) safety, or (c) bioequivalence studies in the case of generic drugs	2.002.71
7.5	Rate for tracking advice for assumptions included under item 7.2
	7.6, 71	7.6	7.6	7.6	1.515.57
	Rate for tracking advice for assumptions included under heading 7.4	974.30
	Assessment fee for classification of variations not classified under Article 5, and for grouping of variations, as provided for in Article 7 of Commission Regulation (EC) 1234/2008 European	487.14
	Rate for scientific advice on medicines for use paediatric in any of the assumptions included in the above headings	202.98
7.10	Scientific/Technical Advice on Design of Facility and Manufacturing Processes with the correct manufacturing rules	487.14

Group VIII. Healthcare products, cosmetics and personal care products

Epiphon

8.30

Description	Euros
8.1	Cosmetics special declaration procedure	483.07
8.2	Individual registration and authorization procedure for products personal care and disinfectants	483.07
8.3	Registration and registration procedure sanitary products
8.4	Product validation and modification procedure Personal care and disinfectants	168.34
8.5	Certification expedition procedure	146.36
8.6	The check and control procedure for the declaration responsible for the manufacturing activity of cosmetic and personal care products	709.98
	Check and control procedure for the declaration responsible for the import of cosmetic and personal care products	365.97
8.8	The check and control procedure for the declaration responsible for changes in the manufacturing activity of cosmetic and care products personal	365.97
8.9	The check and control procedure for the declaration responsible for modifying the import activity for cosmetic and personal care products	168.34
8.10	Individualized inspecting actuations for declaration checking responsible	709.98
8.11	Cosmetic ingredients confidentiality authorization procedure	483.07
8.12	Pre-operating license procedure for sanitary products and disinfectants: manufacturing establishment, pool	709.98
	8.13	Pre-license procedure for sanitary products and disinfectants: import establishment	365.97
8.14	Procedure for modifying the operating license of health product and disinfectant establishments prior to their placement: manufacturing, grouping	709.98
8.15	Procedure for modifying the previous operating license of sanitary products and disinfectants in the concerning your placement: import establishment	365.97
8.16	Procedure modification of the prior operating licence of establishments of medical devices and disinfectants	168.34
8.17	Establishments License Revalidation Procedure for sanitary products and disinfectants: manufacturing facility	512.35
8.18	Revalidation procedure for the health products and disinfectant establishments license: import establishment	314.73
8.19	Authorization of clinical investigations of health products	800.00
8.20	Active principle assessment report incorporated into a health product	1.463.86
8.21	Evaluation of CE marked "CE" marking of health products belonging to the same family by quality assurance system	2.436.00
8.22	Evaluation of certification files for the CE marking of health products by 'EC' type examination, combined with quality assurance of production, 'EC' verification or guarantee Product quality	878.32
8.23	Marking Certification File Assessment 'EC' of medical devices belonging to the same family, by 'EC' declaration of conformity combined with quality assurance of production, 'EC' verification or product quality assurance	8.24
	8.24	8.24	8.25
	8.25	8.25	8.25	8.25 Table_table_izq"> Certification case assessment of the "CE" marking of health products by design "CE" examination	1,610.27
8.26	Quality assurance full system initial audit	8.27
8.27	Initial Audit according to production quality assurance	8.28
	8.28	8.28	8.28	Table_table_der" >2.133.00
	8.29	2.133.00
	8.30	8.30	8.30	8.30	1.067.00
8.31	8.31	8.31	8.31	8.31 Table_table_izq"> Modification of administrative data in CE marking certification	8.32
8.32	8.32	8.32		146.36
8.33	Healthcare Product Modification Procedure

Group IX. Veterinary medicinal products

Epiphon

9.2

Description	Euros
9.1	Rate per marketing authorization request for a veterinary medicinal product, except for requests referred to in Article 17.3	10.264.57
Rate per marketing authorization request for a generic veterinary medicinal product (case submitted in accordance with article 17.3)	4.175.35
9.3	Rate by the transmission procedure of the entitlement of a veterinary medicinal product, or by modification of the owner's representative	697.57
9.4	Rate by the procedure for modifying the authorization of a veterinary medicinal product, qualified as "major" Type II	3.525, 87
	9.5	Rate by procedure for modifying the authorization of a veterinary medicinal product, defined as Type IB	1.212.59
9.6	Rate by the procedure for modifying the authorization of a veterinary medicinal product, qualified as type IA (including immediate notification AI type)	717.25
9.7	Rate by procedure of renewal of a drug's authorization veterinarian	2.319.51
9.8	Rate per simple annual declaration of intent to market an already authorized veterinary medicinal product	119.01
	Rate by authorization procedure for "parallel import" of a veterinary medicinal product	731.61
9.10	Rate by periodic report evaluation evaluation of a veterinary medicinal product, this or not registered the drug in Spain	378.92
9.11	Rate by annual report assessment of a veterinary medicinal product, whether or not the product is registered in Spain	9.12
9.12	Rate per three-year, three-year periodic safety report evaluation of a veterinary medicinal product, whether or not the drug is registered in Spain	2.228.76
9.13	Rate by issue of European certificate of official batch release for veterinary immunological drugs as per Article 81 of Directive 2001 /82/EC	336.00
9.14	Rate by issue of European certificate of official batch release for immunological veterinary medicinal products under Article 82 of the Directive 2001 /82/EC	1,200,00
9.15	Rate for the reservation of a vacancy to act Spain as a State Reference member in a Decentralized or Mutual Recognition procedure	400.00

Group X. Financing procedures from public funds and pricing of healthcare products

Epiphon

Description	Euros
10.1	A healthcare product inclusion procedure in the National Health System pharmaceutical delivery	344.46
10.2	Exclusion procedure for a healthcare product in the National Health System pharmaceutical delivery	344.46

2. For the purposes of the preceding paragraph, the second and successive applications for authorisation and registration in the register of other pharmaceutical forms, routes of administration and concentration of an already authorised medicinal product shall be understood as an extension of line. and enrolled.

The rate of the rate of line extensions will be seventy percent of the first authorization of the medication.

In the case of medicinal products for veterinary use, the extension of an authorisation to new target species will be considered as an extension of the line provided that they are food producing species.

They will constitute an extension of line those modifications that require the submission of a new application for authorization, in accordance with the European norm that regulates the modifications of authorization of medications granted by the competent authority of a Member State.

The provisions in the preceding paragraphs concerning the line extensions are also applicable when the product is not yet authorized and line extensions of a main application are presented in parallel.

For the purposes of the rate described in paragraphs 8.1 and 8.21, you have the consideration of:

(a) "cosmetic product subject to a special declaration", which, subject to the corresponding authorisation of the Spanish Agency for Medicinal Products and Health Products, includes colouring agents, preservatives or Ultraviolet filters, not included among the substances admitted as components of cosmetic products.

(b) "Family of medical devices" means a set of medical devices which, belonging to the same category, are intended for identical or similar sanitary applications.

3. The amount of the fees for the services and activities of the General Administration of the State in the field of medicinal products, medical devices, cosmetic products and personal care products, as provided for in Law 8/1989, of 13 of April, of Public Fees and Prices, may be modified through the State General Budget Law.

4. Where the assessment and control of a medicinal product or medical device requires action abroad or exceptional costs, the corresponding fees shall be settled on the actual cost of the service in which the case is determined. requirement.

The actual cost of the service shall also be settled for the costs of travel, subsistence and testing resulting from the actions referred to in the headings 6.1, 6.4 (a) (b) and (c), 8.22, 8.24, 8.26, 8.27, 8.28, 8.29, 8.30 and 10.1.

5. Where in the authorisation and registration procedure for registration of a medicinal product for human or veterinary use, which corresponds to the fees provided for in the headings 1.1, 1.2, 1.3, 1.5, 9.1, 9.2 and 9.4, the application submitted shall be rejected In the validation phase, 70 percent of the total amount of the fee will be returned.

For the purposes of this Law, the administrative action, developed for the purpose of verifying that the application meets all the necessary requirements to carry out the providing the service or performing the administrative activity.

6. Amendments to the authorisation of a medicinal product, which are the result of a decision of the European Commission and which do not involve scientific evaluation by the Spanish Agency for Medicinal Products and Products, will become the fee provided for under heading 1.19.

In cases of grouping of independent modifications Type IA, being these same or different, affecting several drugs belonging to the same holder and whenever they are presented at the same time and in a single format on request in accordance with Article 7 of Commission Regulation (EC) No 1234/2008 of 24 November 2008 on the examination of amendments to the terms of the marketing authorisations for medicinal products for human use and Veterinary medicinal products shall bear each of the following types of modifications: main rate and reduced rates for the rest of the modifications.

When a modification affects different medicinal products from the same holder, and which involves a single scientific assessment, the second and subsequent evaluation shall bear the fee provided for under heading 1.19.

When different modifications are made to the authorization to place a medicinal product on the market, the total amount of the medicinal product may not exceed the rate laid down for the authorization and registration procedure in the Record of the type of medicinal product concerned.

In the case of a grouping of independent modifications affecting the same medicinal product and provided that all are submitted at the same time and in a single application format, in accordance with Article 7 of Regulation 1234/2008 the European Commission, a fee shall be required for each of the amendments requested.

The rate for epigraph 7.2, " Rate for scientific advice for drugs that include multidisciplinary questions on (a) quality, safety and clinical development, or (b) quality and clinical development, or (c) safety and clinical development, or (d) pre-referral advice for a dossier " shall be reduced by 25 per 100 for scientific advice including questions on development only of: Clinical efficacy; or pre-clinical quality and safety; or bioequivalences.

7. The rates of decentralised procedures for medicinal products for human or veterinary use, resulting in a national authorisation in which Spain acts as a reference Member State (subject to the provisions of headings 1.1, 1.2, 1.3, 1.5, 1.6, 1.7, 1.8, 3.1, 3.3, 3.5, 3.6, 3.7, 4.1, 4.2, 4.3, 4.5, 4.7, 4.8, 4.9, 9.1, 9.2, 9.4, 9.5, 9.6 and 9.7) will be increased by 25% on the corresponding rate.

In mutual recognition procedures for medicinal products for human or veterinary use in which Spain acts as a reference Member State, a third part of the full reference rate shall be paid (benefits 1.1, 1.2, 1.3, 3.1, 3.3, 4.1, 4.2, 4.3, 4.5, 9.1 and 9.2).

The rate of heading 1.20, which shall apply to any medicinal product for human use, including special medicinal products, shall be deducted from the total amount to be paid if the person concerned presents a a request for a decentralised or mutual recognition procedure, acting as a reference Member State.

The rate of heading 9.15, which shall apply to any veterinary medicinal product, shall be deducted from the total amount to be paid if the person concerned submits an application for a procedure. decentralised or mutual recognition, acting as a Member State of reference. '

Sixty. Article 112 is worded as follows:

" Article 112. Accrual.

The fee will become payable when the application, which starts the file, has entry in the register of the Spanish Agency for Medicines and Health Products or the Ministry of Health, Social Services and Equality, according to its respective jurisdiction, at which time the service is initiated or the performance of the administrative activity is initiated. '

Sixty-one. Article 113 (1) is hereby worded as

:

" 1. The fee shall be paid in accordance with the provisions of Law 8/1989, of 13 April, of Public Fees and Prices; Law 58/2003 of 17 December, General Tax and other implementing rules.

The payment of the fees referred to in this Law will be made, preferably, by way or electronic means, as provided for in Law 11/2007, of June 22, of Electronic Access of Citizens to Public Services. "

Sixty-two. Article 113 (4) is hereby worded as

:

" 4. If the fee is paid, the taxable person shall submit the corresponding application within 10 days of entry. "

Sixty-three. A new paragraph 6 is added to Article 113 with the following wording:

" 6. The Spanish Agency for Medicines and Health Products may use to obtain the effectiveness of its debits in the nature of public law, the administrative procedure of the award, provided that such debits are in period executive. The Spanish Agency for Medicinal Products and Sanitary Products may agree with the State Administration of Tax Administration to collect its revenue from public law in the form provided for in the General Rules of Collection, approved by Royal Decree 939/2005 of 29 July. '

Sixty-four. A new Article 114 is added, with the following wording:

" Article 114. Rate-return assumptions.

The return of income by fees shall be carried out, in addition to the assumptions referred to in Article 221 of Law 58/2003 of 17 December, General Tax, when the fee is paid, the taxable person does not submit the the provision of the relevant service or activity within a period of 10 days following the entry laid down in Article 113.4, provided that the taxable person is not responsible for the purposes of the service. This refund will be eighty percent of its amount. "

Sixty-five. The third additional provision is worded as follows:

" Additional provision third. Application of the Law to medical devices, cosmetics and personal care products.

1. In accordance with the provisions of this Law, the conditions and requirements for the manufacture, import, clinical investigation, distribution, marketing, placing on the market, placing on the market, shall be determined. service, dispensing and use, as well as the respective administrative procedures, in accordance with the provisions of the European Union legislation.

2. The provisions of the preceding paragraph shall also apply, where appropriate, to personal care and cosmetic products.

3. The manufacturing and import activities of cosmetics and personal care products are subject to the system of responsible declaration, as laid down in Article 71a of Law 30/1992 of 26 December 1992, of the Legal Regime of the Administrations. Public and the Common Administrative Procedure. This responsible statement must be submitted to the Spanish Agency for Medicines and Health Products. The presentation of the responsible declaration shall allow for the initiation of the activities, without prejudice to the subsequent verification by the Spanish Agency for Medicinal Products and Health Products, by means of documentary verification and, where appropriate, inspection, of the elements and circumstances highlighted by the person concerned in the responsible declaration.

4. The fees necessary shall be payable to cover the costs of verification of the responsible declaration and of the inspection which, where appropriate, is necessary. '

Sixty-six. A new additional provision is added fifteenth, with the following wording:

" Additional Disposition 15th. Derogation from the legal regime provided for in Article 43 (1) of Law 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure.

1. Without prejudice to the procedures referred to in the additional twenty-ninth provision of Law 14/2000 of 29 December, of fiscal, administrative and social measures, corresponding to the derogation provided for in paragraph 1 of the Article 43 of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure shall be construed as including the following:

a) Authorization and major modifications of pharmaceutical laboratories.

b) Authorization for the import, export and manufacture of unregistered medicinal products.

c) Exceptional authorization to export medicines for humanitarian donations.

d) Declaration of galenic innovation of therapeutic interest.

e) Authorization, modification and renewal of parallel import of medicinal products.

f) Authorisation of medicinal products by decentralised procedure between European Union States.

2. The procedure for the registration and authorisation of medical devices not included in the scope of Royal Decree 1616/2009 of 26 October, governing the active implantable medical devices, and the Royal Decree 1591/2009, of 16 October 2009, for which medical devices are regulated, as laid down in the additional twenty-ninth provision of Law 14/2000, of 29 December, is excluded from the derogation provided for in Article 43 (1) of the Law 30/1992, dated November 26. "

Sixty-seven. The additional 13th provision is amended, with the following wording:

" The placement or delivery of medical devices by an optional, in the exercise of their professional privileges, shall not be considered as dispensing, marketing, selling, distributing, supplying or putting up on the market for the same, for the purposes of Articles 3.1 and 101. In any case, the optional must separate its fees from the manufacturing costs. "

Sixty-eight. The wording of the second transitional provision is amended as follows:

" Second transient disposition. Conflict of interest.

Without prejudice to compliance with the provisions of this Law, and in particular Article 3 thereof, pharmacists in professional practice with a pharmacy office, in retail establishment, in entities or groups Livestock or in a service of hospital pharmacy and other care structures, which at the entry into force of this Law have direct economic interests in authorized pharmaceutical laboratories, will be able to maintain those interests until the extinction of the authorization or transfer of the laboratory.

Also, the pharmacists listed in the preceding paragraph who are a party or who may become part of cooperatives with a minimum of 20 cooperatives or commercial companies with a minimum of 100 shareholders or partners, in both cases exclusively by the pharmaceutical companies and already existing at the entry into force of this provision, may participate in them until their dissolution, provided that the same does not entail a possible conflict of interests. "

Sixty-nine. Paragraphs 1, 2 and 3 of the first final provision are amended as follows:

" 1. Titles I; II, except Article 38; III; IV, except Articles 68 to 71 of Chapter II; V; Articles 75.2, 76, 78 to 80, 82 and 85 to 87 of Title VI; Articles 90 to 93a of Title VII; and VIII; the first provisions, second and seventh, as well as the transitional provisions, have the status of legislation on pharmaceutical products and are dictated under article 149.1.16. of the Constitution.

2. Articles 38, 68 to 71, 75.1, 3, 4 and 5, 77, 81, 83, 84 and 95 to 97 ter and the additional third and fourth provisions, have the status of basic rules and are dictated by Article 149.1.16. of the Constitution, which it attributes to the State exclusive competence in the field of basic and general health coordination.

3. Articles 88, 89 and 94 to 94 b, as well as the fifth and sixth additional provisions, are laid down in accordance with Article 149.1.17 of the Constitution, which confers exclusive competence on the State in the field of the economic system of security Social. "

Additional disposition first. Change of name of 'personal hygiene products' to 'personal care products'.

From the entry into force of this Law, "personal hygiene products" will be referred to as "personal care products"; consequently, all references to "personal hygiene products" made, both in the Law 29/2006, of 26 July, subject to amendment, as in its implementing legislation, or any other legislation which may result from its application, shall be construed as "personal care products".

Additional provision second. No increase in staff expenditure.

The application of this Law will not result in any increase in personnel spending. The new human resources needs that may arise as a result of the regulatory obligations set out in this Law must be met through the redistribution of places.

Additional provision third. Drug positioning.

The actions aimed at establishing the position of a drug in the pharmaceutical supply and its comparison with other therapeutic alternatives, will have a common technical scientific basis for the entire National Health System. and will be carried out in the framework of the positioning reports of the Spanish Agency for the Medicines and Health Products. Such reports shall be binding.

Additional provision fourth. Replacement of the term "wholesale warehouse" or "wholesale distribution warehouse" by "distribution entity".

As of the entry into force of this Law, all references made in Law 29/2006, of July 26, to "wholesale warehouse" or "wholesale distribution warehouse" shall be construed as being made to "distribution entity" of agreement with the scope of authorization of the same.

Single transient arrangement. Payment of fees by way or means of non-electronic means.

Until 1 January 2014, the payment of the fees referred to in Law 29/2006, of 26 July, of guarantees and the rational use of medicinal products and medical devices, may continue to be carried out, preferably, by way or means electronic.

Single repeal provision. Regulatory repeal.

The provisions of this Law and, in particular, paragraph 2 of Article 102 of Law 14/1986 of 25 April of 25 April, General of Health; Chapter XII of Royal Decree 1591/2009 of 16 December 2009, are repealed. The Court of the European Court of 29 October 2000, Chapter XII of Royal Decree 1616/2009 of 26 October 2000 on active implantable medical devices, Chapter VIII of Royal Decree 1662/2000 of 29 June 2000 on the protection of medical devices September, on in vitro diagnostic medical devices and Chapter VIII of Royal Decree 1599/1997, of 17 October, on the basis of which cosmetic products are regulated.

Final disposition first. Amendment of Royal Decree-Law 8/2011 of 1 July 2011 of measures to support mortgage debtors, control of public expenditure and the cancellation of debts owed to companies and the self-employed by local authorities, to promote the activity Business and the promotion of rehabilitation and administrative simplification.

In Annex I of Royal Decree-Law 8/2011 of 1 July 2011, measures to support mortgage debtors, control of public expenditure and the cancellation of debts with companies and self-employed persons contracted by local authorities, of the business activity and impulse of the rehabilitation and administrative simplification, relative to the administrative procedures with a sense of the negative silence that passes to positive, the reference to the procedure relative to the Clinical trial authorisations and/or clinical research phase products governing the Royal Decree 109/1995 of 27 January 1995 on veterinary medicinal products, as follows:

Procedure

Regulatory Rule	Article	Resolution
Authorization of clinical trials and clinical research products with veterinary drugs, except for the following assumptions: b) Clinical trials with medicinal products containing genetically modified organisms and medicinal products c) Clinical trials with immunological drugs.	Law 14/2000 of 29 November, of Fiscal, Administrative and Social Order Measures. Royal Decree 109/1995 of 27 January on medicinal products Order PRE/2938/2004, of 7 September, for which the Royal Decree 109/1995, of 27 January, is developed, regarding the qualification of products in the phase of clinical research and realization of clinical trials with medicines for veterinary use.	Additional disposal 29. Article 56. Articles 5 and 12.	30 calendar days

Final disposition second. Competence title.

The provisions of the sole article of this Law are dictated by the following State competence titles:

1. Paragraphs one to eighteen, twenty to twenty-three, twenty-six to thirty-eight and forty to fifty six, as well as sixty-seven have the status of legislation on pharmaceutical products and are dictated under the protection of Article 149.1.16. the Constitution.

2. Paragraphs 19, 24 and 25, the additional first provision and the fourth additional provision have the status of basic rules and are dictated by Article 149.1.16. of the Constitution, which it attributes to the State exclusive competence in the field of basic and general health coordination.

3. Paragraph thirty-nine is issued under Article 149.1.17 of the Constitution, which confers exclusive competence on the State in matters of the economic regime of social security.

4. Paragraphs fifty-seven to sixty-five are given in accordance with Article 149.1.14. of the Constitution, which gives the State exclusive competence in matters of general taxation.

5. Paragraph 60 and six, and the final provision first, are issued under Article 149.1.18 of the Constitution, which confers exclusive competence on the State in the field of the legal system of public administrations.

Final disposition third. Incorporation of Community law.

By this Law, the following directives are partially incorporated into Spanish law:

1. Directive 2010 /84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001 /83/EC on the Community code relating to medicinal products for human use.

2. Directive 2011 /62/EU of the European Parliament and of the Council of 8 June 2011 amending, as regards the prevention of the entry of falsified medicinal products into the legal supply chain, Directive 2001 /83/EC on establishes a Community code on medicinal products for human use.

Final disposition fourth. Authorization to draw up a recast text.

In order to consolidate in a single text the amendments incorporated, since its entry into force, in Law 29/2006, of 26 July, of guarantees and rational use of medicines and medical devices, the Government is authorised to draw up and approve, within two years of the entry into force of this Law, a recast text of the Law on the guarantees and rational use of medicinal products and medical devices. This authorisation includes the right to regularise, clarify and harmonise legal texts to be recast.

Final disposition fifth. Amendment of Law 55/2003 of 16 December of the Staff Regulations Staff Regulations of Health Services.

Law 55/2003 of 16 December, of the Staff Regulations Staff Regulations, is amended as follows:

One. Article 63 (1), which is worded as follows, is amended as follows:

" Article 63. Active service.

1. Statutory staff shall be on active duty when they provide the services corresponding to their appointment as such, or where they perform clinical management functions, whatever the health service, institution or centre in which they are he is destined, as well as when he is in the position of working in the relations of posts of public administrations open to the statutory staff. "

Two. A new Article 65a is included, with the following wording:

" Article 65a. Clinical management services.

The status of clinical management services shall be declared to the fixed statutory staff who voluntarily accept the change in their employment relationship which is offered to them by the health services to access these functions, when the nature of the institutions in which the clinical management functions are developed do not allow them to provide their services as fixed statutory staff. In this situation, this staff shall be entitled to the computation of time for the purposes of seniority, as well as to the reservation of its place of origin. "

Three. A new transitional arrangement eighth is included, with the following terms:

" Transient disposition octave. Move to the situation of clinical management services from situations other than active service.

1. The statutory staff fixed that, finding themselves in the situation of services under another legal regime of Article 65 of Law 55/2003, of 16 December, will be able to perform functions of clinical management, will be declared in the situation of services of clinical management with the following effects:

(a) If you are within the first three years of the service situation under another legal regime, you will be entitled in this new situation to the computation of time for the purpose of seniority and the reinstatement to the service active in the same category and area of health of origin or, if this is not possible, in areas bordering on that.

(b) If you have already exceeded the first three years in the service situation under another legal regime, you will be entitled only to the time count for the purposes of seniority.

2. In addition, the statutory staff who pass on to the situation of clinical management services from a situation which does not contain a reservation of a place or right to return, shall be entitled to the time-count only for the purposes of seniority. "

Final disposition sixth. Amendment of Law 44/2003, of 21 November, for the Management of Health Professions.

Law 44/2003 of 21 November of the Management of Health Professions is amended in the following terms:

One. Article 19 (2) is amended to read as follows:

" 2. Specialties in Health Sciences shall be grouped, where appropriate, on the basis of high quality criteria. The specialties of the same trunk shall have a common training period of a duration of two years.

However, the Ministry of Health, Social Services and Equality, prior to the report of the national committees of the specialties involved, of the National Council of Specialties in Health Sciences, and of the Commission of Human resources of the National Health System, may decrease or increase the length of the trunk period up to a maximum of six months, according to the competencies to be acquired in the troncal training period in question. In these cases, the assessments referred to in Article 20 (2) (e) of this Law shall be in accordance with the terms to be determined in accordance with the rules governing the new duration of the training periods. "

Two. A new paragraph 5 is added to Article 10 with the following wording:

" 5. The Government will develop regulations as laid down in the previous paragraphs, establishing the general principles and characteristics of clinical management, and the guarantees for professionals who choose not to access them. functions. "

Final disposition seventh. Amendment of Law 10/1986 of 17 March on Odontologists and other dental health professionals.

The additional provision of Law 10/1986 of March 17 on Dentistry and other dental health professionals is modified, which happens to have the following wording:

" Additional Disposition.

This Law in no way limits the professional capacity as dentists of medical specialists in Estomatology who, in accordance with the Community rules, have recognized the right acquired to exercise the functions mentioned in the first article of this Law.

The above paragraph is without prejudice to the fact that the Medical Specialists in Oral and Maxillofacial Surgery carry out activities corresponding to their specialty in the field of the oral cavity, provided that they do not exercise the profession of dentist. "

Final disposition octave. Amendment of the Recast Text of the Law on Public Sector Contracts, approved by Royal Legislative Decree 3/2011 of 14 November.

A new paragraph 4 is added to the additional twenty-eighth provision of the Royal Legislative Decree 3/2011 of 14 November, approving the recast of the Law on Public Sector Contracts, which will have the following wording:

" 4. The measures laid down in Articles 9 and 10, third paragraph, of Royal Decree-Law No 8/2010 of 20 May, laying down extraordinary measures for the reduction of the public deficit, to contracts arising from the purchase of medicinal products promoted under the provisions of this additional provision provided that the savings resulting from the centralised purchase are higher than the deductions set out in those articles of the Royal Decree-Law 8/2010 of 29 May. "

Final disposition ninth. Entry into force.

This Law will enter into force on the day following its publication in the "Official State Gazette".

Therefore,

I command all Spaniards, individuals and authorities, to keep and keep this law.

Madrid, 24 July 2013.

JOHN CARLOS R.

The President of the Government,

MARIANO RAJOY BREY