Law 29/2006, of July 26, of guarantees and rational use of medicines and medical devices, establishes the submission to administrative authorization prior to the marketing of the medicinal products, as well as any modification of the conditions under which they were authorised.

Royal Decree 1345/2007 of 11 October, regulating the procedure for the authorization, registration and conditions for the supply of medicinal products for human use manufactured industrially, developed the This law provides in detail for the procedures for the authorisation of medicinal products for human use, as well as the procedures for amending the authorisations already granted.

This royal decree transposed into national law Directive 2001 /83/EC of the European Parliament and of the Council of 6 November establishing a Community code for medicinal products for human use.

However, in view of the experience gained and following an evaluation by the European Commission of the pharmacovigilance system of the European Union, the need for measures to improve the functioning of the system has been highlighted. European Union law on the pharmacovigilance of medicinal products, as amended by Directive 2001 /83/EC, which has been carried out by Directive 2010 /84/EU of the European Parliament and of the Council of 15 December 2001 on the protection of medicinal products December 2010, and Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2010 2012, amending in respect of pharmacovigilance, Directive 2001 /83/EC establishing a Community code on medicinal products for human use.

The aforementioned directives have been the subject of partial transposition into national law through Royal Decree 577/2013 of 26 July 2013 regulating the pharmacovigilance of medicinal products for human use.

Consequently, with this royal decree is updated and adapted to the technical progress the regulation up to now in force in this matter, collected in Royal Decree 1345/2007, of October 11, and are incorporated into the legal order (a) the new developments introduced by Directive 2010 /84/EU of the European Parliament and of the Council of 15 December 2010 and Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012. These developments are numerous and of great relevance, although most have been transposed through Royal Decree 577/2013 of 26 July.

However, some of these novelties mentioned in the previous paragraph are incorporated into this royal decree, as is the appointment of the Spanish representative in the coordination group, whose creation was already foreseen in the Previous wording of Article 27 of Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2010 and which, by way of this new Directive 2010 /84/EU of the European Parliament and of the Council of 15 December 2010, only is to be updated.

The coordination group is the body at European level responsible for examining all issues relating to marketing authorisations for medicinal products authorised by European procedures, mutual recognition and decentralised procedure. In addition, for the fulfilment of all the pharmacovigilance functions set out in Articles 107c, 107e, 107g and 107q of Directive 2001 /83/EC of the European Parliament and of the Council of 6 November, the Coordination Group shall be based on the scientific evaluations and recommendations of the Pharmacovigilance Risk Assessment Committee set out in Article 56 (1) (a) of Regulation (EC) No 726/2004.

This royal decree seeks to update the wording of the exclusion concerning certain advanced therapy medicinal products from its scope, in order to make it consistent with the modification of the Article 3 (7) of Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use relating to advanced therapy medicinal products the entry into force of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007, on advanced therapy drugs.

In addition, this royal decree incorporates into law the forecasts made in this field by Directive 2011 /62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001 /83/EC on the on the prevention of the entry of counterfeit medicinal products into the legal supply chain.

Therefore, this royal decree is intended to amend Royal Decree 1345/2007 of 11 October 2007 in order to conclude the transposition of Directive 2010 /84/EU of the European Parliament and of the Council of 15 December 2007. 2010, as well as Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012, updating the procedures for the marketing authorisation of medicinal products for adaptation to medicinal products, at the same time as they are established the administrative consequences which, for reasons of safety, may affect the conditions of authorisation to place medicinal products for human use on the market, and, in addition, incorporating both the regulation of certain advanced therapy medicinal products and the other amendments introduced in its field of application by the different related European regulations.

In the elaboration of this royal decree, the autonomous communities and the cities with autonomy status have been consulted, having submitted to the prior report of the Advisory Committee of the National Health System and to the Interterritorial Council of the National Health System. The sectors concerned have been heard. It has also been submitted to the Consumer and Users Council and the Spanish Data Protection Agency.

This rule is dictated in development as provided for in Law 29/2006 of July 26, and under the provisions of Article 149.1.16. of the Constitution, which attributes exclusive competence to the State in matters of law pharmaceutical products, guaranteeing, as regards the processing of personal data, the respect of the Organic Law 15/1999, of December 13, of Protection of Personal Data, and its regulations of development.

In its virtue, on the proposal of the Minister of Health, Social Services and Equality, with the prior approval of the Minister of Finance and Public Administrations, in agreement with the Council of State and after deliberation of the Council of Ministers at their meeting on 13 September 2013,

DISPONGO:

Single item. Amendment of Royal Decree 1345/2007 of 11 October 2007 regulating the procedure for the authorisation, registration and dispensing of medicinal products for human use manufactured industrially.

Royal Decree 1345/2007 of 11 October, which regulates the procedure for the authorisation, registration and dispensing of medicinal products for human use manufactured industrially, is amended as follows:

One. Article 2 (2) and (3) are worded as follows:

" 2. Active substance or active substance: 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 take action pharmacological, immunological or metabolic in order to restore, correct or modify physiological functions, or to establish a diagnosis.

3. Excipient: Any component of a medicinal product other than the active substance and the packaging material. '

Two. Article 3 (2) (a) is worded as follows:

" (a) The advanced therapy medicinal products referred to in Article 47 of Law 29/2006 of 26 July, as defined in Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on medicines for advanced therapy and amending Directive 2001 /83/EC and Regulation (EC) No 726/2004, prepared occasionally, in accordance with specific quality standards, and used in Spain, in a hospital institution and under the the sole professional responsibility of a collegiate doctor, in order to comply with a individual optional prescription of a tailor-made product intended for a single patient, and are medicinal products in the clinical investigation phase or are medicinal products which the Spanish Agency for Medicines and Health Products considers to be satisfy the guarantees of quality, safety, efficacy, identification and information. "

Three. Article 6 (5) (k) is worded as follows:

" k) a summary of the pharmacovigilance system of the applicant, including:

1. Proof that the applicant has the services of a qualified person responsible for pharmacovigilance,

2. The Member States in which the qualified person resides and performs his/her duties,

3. Qualified Person Contact Data,

4. Declaration signed by the applicant certifying that he has the necessary means to perform the duties and to assume the responsibilities defined in the pharmacovigilance regulations,

5. Reference to the location of the drug pharmacovigilance system master file; "

Four. A new point (l) is added to Article 6 (5), passing the current content of this point to (m), as well as the current contents of letters (m), (n) and (n) to (n), (n), and (o), respectively, with the following wording:

" l) The risk management plan with the description of the risk management system that the applicant is to prepare for the medicinal product, together with a summary.

The risk management system shall be proportionate to the identified or potential risks of the medicinal product, and to the need for post-authorisation safety data, the information being updated when proceed; '

Five. Article 6 (5) (b), new point (n), new point (o), is hereby worded as follows:

" o) Copies of the following documentation:

1. º Where appropriate, a copy of the marketing authorisation obtained in another Member State or in a third country, together with the technical information sheet and a summary of the safety data, including the data contained in the reports updated safety papers, where available, and notifications of suspected adverse reactions, together with the list of Member States in which an application for authorisation is being considered,

2. The technical fiche proposed by the applicant pursuant to Annex II or approved by the competent authorities of the Member State, and the prospectus proposed in accordance with Annexes IV and V or approved by the competent authority of the Member State,

3. Details of any decision to refuse authorisation, both in the European Union and in a third country, and the reasons for such a decision. "

Six. The content of the current Article 6 (5) (o) shall be deleted, the content of which shall be as set out in the preceding paragraph.

Seven. A new point (p) is added to Article 6 (5) with the following wording:

" (p) Proof of evidence that the manufacturer of the medicinal product has verified through audits that the manufacturer of the active substance has complied with the principles and guidelines of the correct manufacturing standards. This document will contain a reference to the date of the audit, as well as to the fact that its result confirms that the manufacturing is in accordance with the principles and guidelines of those standards of correct manufacturing. "

Eight. A new point 4 is added to Article 17 with the following wording:

" 4. In addition to the above, a marketing authorisation may be granted for a medicinal product subject to compliance with one or more of the following conditions:

(a) Certain measures are taken to ensure the safe use of the medicinal product to be included in the risk management system;

b) Post-authorization security studies are performed;

(c) Obligations on the registration or reporting of suspected adverse reactions that are more stringent than those provided for in the current pharmacovigilance rules for medicinal products for human use are fulfilled.

d) Any other conditions or restrictions related to the safe and effective use of the medicinal product;

e) The pharmacovigilance system is adequate;

(f) Post-authorisation efficacy studies are carried out when questions are raised about the efficacy of the medicinal product which can only be resolved after the medicinal product is placed on the market. The obligation to carry out such studies shall be based on the delegated acts adopted in accordance with European legislation. "

Nine. Two new points (m) and (n) are added to Article 20 (4), with the following wording:

" m) Post-authorisation studies where appropriate and deadlines for compliance.

n) Frequency for the submission of periodic safety update reports. "

Ten. A new Article 20a is added, with the following wording:

" Article 20a. Post-authorization requirements.

1. After the granting of a marketing authorisation, the Spanish Agency for Medicinal Products and Sanitary Products may bind the marketing authorisation holder:

(a) To carry out a post-authorisation safety study in case of concern for the risks of the authorised medicinal product. Where the same concern affects more than one medicinal product, the Spanish Agency for Medicinal Products and Sanitary Products after consulting the Committee for the Safety of Medicinal Products for Human Use, where appropriate, shall require the holder or holders of the the marketing authorisation in question to be carried out jointly by a post-authorisation safety study;

b) To conduct a post-authorisation efficacy study when knowledge of the disease or clinical methodology indicates that previous efficacy assessments may have to be significantly reviewed.

The Spanish Agency for Medicines and Health Products shall notify the imposition of the obligation, which shall be duly justified, specifying the objectives and the timetable for submission and implementation. of the study.

2. The holder of the marketing authorisation within 30 calendar days following receipt of the notification of the obligation may object.

3. In the light of the objections raised by the marketing authorisation holder, the Spanish Agency for Medicinal Products and Sanitary Products shall withdraw or confirm the obligation. In the event of confirmation of the obligation, the holder shall request the modification of the marketing authorisation to include the obligation as a condition of the authorisation and the risk management system shall be updated accordingly. '

Once. A new Article 21a is added, with the following wording:

" Article 21a. Communication to the European Agency.

The Spanish Agency for Medicinal Products and Sanitary Products shall communicate to the European Medicines Agency the marketing authorisations it has granted under the conditions referred to in Articles 17.4, 20a and 26. "

Twelve. Article 22 is worded as follows:

" Article 22. Transparency and publicity.

1. For each authorised medicinal product, the Spanish Agency for Medicinal Products and Sanitary Products shall make available to the public without delay the marketing authorisation, the package leaflet, the technical information sheet and all the conditions laid down. pursuant to Articles 17.4, 20a and 26 together with all deadlines for the fulfilment of these conditions, in accordance with the provisions of the Organic Law 15/1999 of 13 December on the Protection of Personal Data, and dissociation of personal data.

The Spanish Agency for Medicines and Health Products will draw up an assessment report and make comments on the dossier regarding the results of the pharmaceutical and pre-clinical trials, the tests the clinical risk management system and the pharmacovigilance system of the medicinal product concerned. The assessment report shall be updated when new data are available which are important for the assessment of the quality, safety or efficacy of the medicinal product.

The Spanish Agency for Medicines and Health Products shall make the assessment report and the reasons for the opinion available to the public without delay, after the deletion of any commercial information of a nature confidential, and dissociation of personal data. A separate justification for each of the requested information shall be provided separately.

The public assessment report shall contain a summary drawn up in an understandable manner for the public. The summary shall include, in particular, a section on the conditions of use of the medicinal product.

2. The Spanish Agency for Medicines and Health Products will set up a web portal with information on medicines authorised in Spain. That portal shall also link to the web portal set up in accordance with Article 26 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation of and control of medicinal products for human and veterinary use and for which the European Medicines Agency is established.

The following information will be available on the website of the Spanish Agency for Medicines and Health Products:

a) Public assessment reports, along with a summary.

b) Technical and package leaflets for authorised medicinal products.

c) Summaries of the risk management plans for authorized drugs.

(d) List of medicinal products referred to in Article 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004.

e) Information on the different means for healthcare professionals and patients to report suspected adverse drug reactions to the Spanish Pharmacovigilance System, including the following: structured web forms referred to in Article 25 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004. '

Thirteen. Paragraphs 1 and 2 of Article 27 are worded as follows:

" 1. The authorisation of a medicinal product shall be valid for five years and may be renewed. To this end, the marketing authorisation holder shall provide the Spanish Agency for Medicinal Products and Sanitary Products with a consolidated version of the dossier in relation to the quality, safety and efficacy, including the assessment of the data recorded in the reports of suspected adverse reactions and periodic safety update reports submitted in accordance with the specific pharmacovigilance rules, as well as information on all the amendments made since the granting of the authorisation on the market, at least nine months before the marketing authorisation is no longer valid.

2. Once renewed, the marketing authorisation shall be of unlimited validity unless the Spanish Agency for Medicinal Products and Sanitary Products decides for an additional renewal for five years, in accordance with paragraph 1, for justified reasons pharmacovigilance, including the exposure of an insufficient number of patients to the medicinal product concerned. '

Fourteen. Article 30 (4) is worded as follows:

" 4. Likewise, when the destination of the medicinal product is not direct to the patient, or where there are serious problems with regard to its availability, the Spanish Agency for Medicines and Health Products may dispense with the obligation to do so The following information shall be included in the labelling and package leaflet, without prejudice to any measures deemed necessary to safeguard public health. They may also provide for a total or partial exemption from the obligation for the labelling and the package leaflet to be written in Spanish. "

Fifteen. A new Article 63b is added, with the following wording:

" Article 63 ter. Communication obligations for changes to the marketing authorisation.

1. The marketing authorisation holder shall take account of the methods of manufacture and control of Article 6 (5) (e) and (i), scientific and technical progress and shall make the necessary changes to the methods of manufacture and control. for the medicine to be manufactured and controlled by generally accepted scientific methods.

Such modifications shall be processed as appropriate in accordance with the provisions of this royal decree.

2. The marketing authorisation holder shall immediately communicate to the Spanish Agency for Medicinal Products and Health Products any new information which may involve a modification of the data or documents referred to in this Article. Articles 6, 7, 8, 9, 10, 11 and 12, as well as the annexes to this royal decree.

In particular, the marketing authorisation holder shall immediately inform the Spanish Agency for Medicinal Products and Sanitary Products of any prohibition or restriction imposed by the authorities. the competent authority of any country in which the medicinal product is placed on the market and shall transmit any other new information which may influence the risk-benefit assessment of the medicinal product concerned. The information shall include the positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the marketing authorisation, as well as data on the use of the medicinal product when such use does not conform to the terms of the marketing authorization.

3. The holder of a marketing authorisation shall ensure that the information on the medicinal product is up to date on the basis of the latest scientific knowledge, including the conclusions of the evaluations and the recommendations published in the European medicines web-portal set up in accordance with Article 26 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, without prejudice to the information provided by the Spanish Medicines Agency and Sanitary Products will publish on your web portal. "

Sixteen. Article 68 is worded as follows:

" Article 68. Causes of suspension and revocation.

The Spanish Agency for Medicines and Health Products may agree to suspend, revoke or modify the authorisation of a medicinal product when:

1. The medicine is considered to be harmful.

2. The medicine may not be therapeutically effective. The lack of therapeutic efficacy will be assessed when it comes to the conclusion that therapeutic results of the medicinal product cannot be obtained.

3. Based on the safety data, the medicine has an unfavorable benefit-risk relationship.

4. The medicinal product does not have the authorised quantitative or qualitative composition, or the quality guarantees are not complied with, or the required quality checks are not carried out.

5. The data and information contained in the documentation are erroneous or in breach of the implementing rules in this field.

6. The mode of manufacture of the medicinal product or the control methods used by the manufacturer is not in conformity with those described in the authorisation.

7. For any other cause, posing a foreseeable risk to the health or safety of persons or animals.

8. In any other case in which the European Commission would have agreed. "

seventeen. A new Article 71a is inserted, with the following wording:

" Article 71a. Coordination group.

1. The Spanish Agency for Medicinal Products and Health Products shall appoint a representative in the coordination group for a period of three years. In turn, the Spanish Agency for Medicines and Health Products may appoint an alternate for that group.

This representative will be able to attend meetings accompanied by experts, on the basis of the issues to be dealt with in the Coordination Group.

2. The main functions of the representative of the Spanish Agency for Medicines and Health Products in the Coordination Group are:

a) Participate in discussions on issues related to marketing authorisations for medicinal products in two or more Member States.

b) Participate in decisions on the dates of submission of periodic safety reports, and on the maintenance, suspension or revocation of marketing authorisations as a result of the data pharmacovigilance.

c) Try to agree on a position on the measures to be taken at European level.

3. The representative of the Spanish Agency for Medicines and Health Products and the alternate member of the coordination group shall ensure appropriate coordination between the work of the coordination group and the units of the Spanish Agency of Medicines and Health Products responsible for the validation, evaluation and authorisation of medicinal products and their advisory bodies.

4. In addition, the representative of the Spanish Agency for Medicines and Health Products and the alternate member of the Coordination Group are required to comply with Article 63 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 December In March 2004, as regards transparency, they were obliged, even after having ceased their duties, not to disclose any information which is covered by the obligation of professional secrecy.

5. The Spanish Agency for Medicinal Products and Sanitary Products shall make available to the member of the coordination group, the alternate and the experts the scientific and regulatory resources at its disposal, monitoring at all times the the evaluations carried out and shall also facilitate the activities of their representatives in the Coordination Group and their experts. '

Eighteen. Article 76 is worded as follows:

" Article 76. Decisions of the Union.

1. In specific cases where the interests of the European Union are at stake, any Member State, where appropriate, the Spanish Agency for Medicinal Products and Sanitary Products, the Commission, the applicant or the holder of the authorisation shall use the Committee for Medicinal Products for Human Use of the European Medicines Agency to apply the arbitration procedure before a decision is taken on an application for authorisation, on a suspension or revocation of an authorisation or a any modification of a marketing authorisation that is necessary. Such request shall be accompanied by all available information.

The applicant or the holder of the authorisation shall be informed of the above when the Commission or any Member State makes use of the Committee for Medicinal Products for Human Use of the European Medicines Agency.

2. Where the appeal derives from the assessment carried out by the Spanish Agency for Medicinal Products and Medicinal Products for pharmacovigilance data for an authorised medicinal product, the latter shall refer the matter, after consulting the Committee on Security Medicinal products for Human Use, to the European Committee for the Evaluation of Pharmacovigilance Risks of the European Medicines Agency.

The European Committee for the Evaluation of Risks in Pharmacovigilance shall issue a recommendation to the Medicines Evaluation Committee of the European Medicines Agency or the Coordination Group.

All recommendations adopted under the coordination group will be mandatory in the terms of the coordination group. "

nineteen. A new third additional provision is added with the following wording:

" Additional provision third. Obligations for the risk management system.

The obligation to have a risk management system for the holders of marketing authorisations shall be governed by the provisions of Article 11 of Royal Decree 577/2013 of 26 July 2013 on the pharmacovigilance for medicinal products for human use. "

Twenty. The sixth transitional provision is worded as follows:

" Transitional provision sixth. Homeopathic medicines.

1. The homeopathic medicinal products covered by the second transitional provision of Royal Decree 2208/1994 of 16 November 1994 on homeopathic medicinal products for human use in industrial manufacture must be brought into line with the of this royal decree, as provided for in the following paragraphs.

2. The holders of medicinal products affected by the second transitional provision of Royal Decree 2208/1994 of 16 November, must inform the Spanish Agency of Medicines and Health Products of their intention to adapt to this real decree.

The communication will be made on the computer support that the Spanish Agency for Medicines and Health Products will make available to the headlines through its website and must be produced within three months from the entry into force of the order in which the Ministry of Health, Social Services and Equality will determine the minimum requirements and the procedure for communication. The fee provided for in paragraphs 4.12 or 4.13 of Article 111 of Law 29/2006 of 26 July, as appropriate, shall be paid together with the communication.

After that period, the medicinal products covered by the second transitional provision of Royal Decree 2208/1994 of 16 November 1994 for which the intention to adapt was not communicated, in accordance with the provisions of the This paragraph shall not be placed on the market and must be withdrawn from the market.

3. The Spanish Agency for Medicinal Products and Health Products shall set a timetable for the holders of homeopathic medicinal products which have made the communication provided for in the preceding paragraph to submit applications for registration and documentation necessary to adjust its provisional status and assess the benefit/risk ratio of the product. This application shall be accompanied by proof of the payment of fees for the entries 4.10 and 4.11 of Article 111 of Law 29/2006 of 26 July, as appropriate.

4. In any case, in respect of homeopathic medicinal products which the Spanish Agency for Medicinal Products and Health Products considers as a priority review to ensure the appropriate benefit/risk ratio, the adequacy procedure provided for in this transitional provision must be completed within one year of the entry into force of the order referred to in paragraph 2. '

Twenty-one. A new point 13 is added in Annex II, with the following wording:

" 13. In addition, medicinal products subject to further monitoring should include the following statement together with the name of the medicinal product: "This medicinal product is subject to further monitoring". This declaration shall be preceded by the black symbol referred to in Article 1 of Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the identification of medicinal products for use subject to further monitoring and followed by the appropriate standard explanatory statement.

In addition, for all medicinal products, a standard text, in which health professionals are expressly asked to report any suspected adverse reaction to the Spanish system, will be included in section 4.8. Pharmacovigilance (link to the web form that the Spanish Agency for Medicines and Health Products will establish to the effect). "

Twenty-two. Paragraph (g) of point 1 of Annex IV is deleted.

Twenty-three. Point 5 of Annex V is worded as follows:

" 5. Description of the adverse effects which may be observed during the normal use of the medicinal product and, where appropriate, measures to be taken. The user should be expressly instructed to communicate any adverse effects to his doctor, pharmacist or healthcare professional. In addition, a standard text will be included in this section to inform patients about the possibility of reporting any suspected adverse reactions directly to the Spanish Pharmacovigilance System (link to the web form which the Spanish Agency for Medicines and Health Products will establish for this purpose. "

Twenty-four. A new point 13 is added in Annex V, with the following wording:

" 13. In addition, medicinal products subject to further monitoring should include the following statement together with the name of the medicinal product: "This medicinal product is subject to further monitoring". This declaration shall be preceded by the black symbol referred to in Article 1 of Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 and followed by the appropriate standardised explanatory phrase '.

Single repeal provision. Regulatory repeal.

All provisions of equal or lower rank are repealed to be opposed to what was established in this royal decree.

Final disposition first. Incorporation of European Union law.

By this royal decree, paragraphs 2 and 3, 7 to 16, 18, 19 and 22 of Article 1 of Directive 2010 /84/EU of the European Parliament and of the Council of 15 December 2010 are incorporated into national law. amending, as regards pharmacovigilance, Directive 2001 /83/EC on the Community code relating to medicinal products for human use; and Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2010 on amending Directive 2001 /83/EC as regards pharmacovigilance. As well as the wording given to Article 3 (7) of Directive 2001 /83/EC, by Regulation 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products.

In addition, this royal decree incorporates in the internal legal order Article 1 (3) and (23) of Directive 2011 /62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001 /83/EC, in on the prevention of the entry of counterfeit medicinal products into the legal supply chain.

Final disposition second. Entry into force.

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

Given in Madrid, 16 September 2013.

JOHN CARLOS R.

The Minister of Health, Social Services and Equality,

ANA MATO ADROVER