Read the untranslated law here: http://app.parlamento.pt/webutils/docs/doc.pdf?path=6148523063446f764c3246795a5868774d546f334e7a67774c336470626d6c7561574e7059585270646d467a4c316776644756346447397a4c334277624445794e4331594c6d527659773d3d&fich=ppl124-X.doc&Inline=false
1 PROPOSAL of law No. 124/X explanatory memorandum 1. The current legal regime of pharmacies of workshop dates back mainly to the 60 of the last century. The evolution of society, the dynamism of pharmacies and the profound changes in the sector of Medicine suggest a reform. 2. On the other hand, legislation that sets the framework for this activity was approved at a national and European context without parallel in actuality, for what matters to adapt it to the new reality of the Portuguese society. 3. It is intended to modify a legal regime unsuitable and unjustifiably property access limiter, the rules that restricted exclusively to pharmacists. The Elimination of these restrictive rules considered the developments in the European Union and, at the same time, the national reality. It is intended to balance the free access to the property and avoid the concentration, through a limitation, proportional and appropriate to four pharmacies. In this respect it should be noted that if you want the property of pharmacies be reserved for individuals and commercial companies, allowing, therefore, a tight administrative control of their ownership. Taking into account the particularities of the sector and the healthy competition between pharmacies, the new legislation will strengthen the regime of incompatibilities in relation to property, exploitation and management of pharmacies, either directly or indirectly. The scheme will be characterised by transparency and rigour in the case of legal transactions on the ownership of pharmacies, cominando with the void those that are awarded against the rules imposed or producing a practical effect identical to what the law meant to prohibit. 4. the provisions on penalties applicable are an important modification of the relationship of pharmacies with the State, in the absence of any specific crime. 2 it is not a true decriminalization, but only the recognition of the sufficiency of the current penal law in predicting the types of unlawful criminal relevance pipeline Integrator arising from violation of legal regulations. At the same time, the new scheme will provide a panoply of mere social ordering illegal, applicable to natural and legal persons, expressing the idea of warning and social censorship, through which the Administration claims the will to protect the public interest and assumes the responsibility of the respective application. Being the matter of legislative jurisdiction relative reserve, we decided to propose a draft law, taking into consideration the technical specificity of the legal regime of pharmacies.
So: under d) of paragraph 1 of article 197 of the Constitution, the Government presents to the Assembly of the Republic the following proposal of law: Article 1 subject-matter is granted the Government permission to approve the legal regime of pharmacies of workshop and adapt the General system of administrative offences to offences committed in the exercise of pharmaceutical activity.
Article 2 the present legislative authorization is granted to allow the fixing of conditions of access to ownership of pharmacies to workshop, to establish limits on the number of pharmacies owned and the possibility of trading their permits, proceed to an increase in the number of situations of incompatibility that determine the prohibition of natural or legal persons are owners of pharmacies, eliminate the criminal offences contained in the previous legal regime of the Pharmacy as well as establish a maximum fine amount applicable to offences committed in the exercise of pharmaceutical activity higher than provided for in the general scheme of offences 3.
Article 3 extension Ordinance to be approved under the authorisation granted by this law must establish: a) changing the property of the pharmacy in order to allow all individuals or companies may be owners of pharmacies; b) modification of the maximum number of pharmacies by homeowners, from one to four; c) amendment of the incompatibilities with the ownership of the pharmacy, prohibiting-if the detention and exercise, directly or indirectly, the property, exploitation or the management of pharmacies: i) healthcare-prescribers of medications; II) representative associations of pharmacies, wholesale distribution companies medicines or pharmaceutical companies, or their employees; III) wholesale drug distribution companies; IV) pharmaceutical industry; v) private companies providing health care; vi) subsystems that they in the price of medicines. d) Impossibility of pharmacies being sold, or leased or pierced their exploitation be provided earlier than five years from the day of its opening; and ethical standards provided for Revocation) in law No. 2125, of 20 March 1965, and in Decree-Law No. 48547, of 27 August 1968; f) unlawful criminal disposal provided for in law No. 2125, of 20 March 1965, and in Decree-Law No. 48547, of 27 August 1968; g) fixing the maximum amount of the fines corresponding to the mere social ordering illegal, for violations of the legal provisions of the legal regime of pharmacies workshop, in the amount of € 20,000 in the case of the offender be natural person, and in the amount of € 50,000 in situations where the offender is a legal person 1 4.
Article 4 Duration the legislative authorization granted by this law lasts for 180 days. Seen and approved by the Council of Ministers of 1 March 2007 the Prime Minister, the Minister of the Presidency
Parliamentary Affairs Minister 5 the legal regime of pharmacies workshop, defined in this decree-law lays down an overall framework and sector framework. This action allows the legal reorganization of the pharmacy sector, whose regime dates back to early 60 of the last century. The evolution of society, the dynamism of pharmacies and the profound changes in the sector of Medicine suggest this reform. On the other hand, the legislation now revokes was approved at a national and European context without parallel in actuality, for what matters to adapt it to the new reality of the Portuguese society. 1. This reform modifies an inappropriate legal framework and unjustifiably property access limiter, the rules that restricted exclusively to pharmacists. The Elimination of these restrictive rules considered the developments in the European Union and, at the same time, the national reality. It is intended to balance the free access to the property and avoid the concentration, through a limitation, proportional and appropriate to four pharmacies. In this respect it should be noted that the ownership of pharmacies is reserved for individuals and commercial companies, allowing, therefore, a tight administrative control of their ownership. Taking into account the particularities of the sector and the healthy competition between pharmacies, this Ordinance strengthens the regime of incompatibilities in relation to property, exploitation and management of pharmacies, either directly or indirectly. 2. also worthy of highlight the framework established for the legal status of the owners of pharmacies. In fact, with this decree-law is changing the property of pharmacies that are currently held, inter alia, by private institutions of social solidarity. In the future, these will have to be commercial companies, in order to ensure tax equality with other pharmacies. 3. On the other hand, it should be noted that the previous legislation fostered, over time, the creation of fictitious situations in relation to property, pursuant to an extraordinarily restrictive regime of property transmission among pharmacists. With the change in the legal regime of ownership will allow the regularization of these situations, since we observe the requirements and the limits of ownership and respect the incompatibilities in relation to property, exploitation and management of 6 pharmacies. So, this new regime is characterized by transparency and rigour in the case of legal transactions on the ownership of pharmacies, cominando with the void those that are awarded against the rules now imposed or producing a practical effect identical to that wanted to ban. 4. The present law emphasizes the systematic adjustment of the technical direction of the pharmacy. The vital importance of this matter, in the reorganization of the sector, stands out for two primary reasons. Firstly, the overriding requirement of the direction technique be ensured, in permanence and exclusivity, by a pharmacist subject to ethical rules and demanding, in order to ensure and promote the quality and continuous improvement of the services provided to users. Secondly, the autonomy of the role of technical director WINS relief, taking into account the dissociation between the Pharmacy and property ownership by pharmacist. Thus, precise duties are opposable to the owner, whose control can also be carried out by the Order of pharmacists, under the enhancement of ethical rules. It should be noted that the legal binding technical director to compliance with the General provisions of this decree-law, in particular the promotion of rational use of medicines, the duties of cooperation and pharmacovigilance, reflects the public interest for the business of dispensing medicines. 5. Also deserves a special mention the amendment of provisions relating to pharmacy staff, in obedience to a progressive idea. Now established as a rule that the Pharmacy has a majority of pharmacists. At the same time allows an exception concerning the transformation of pharmacists in pharmacies, in order to facilitate adaptability of its frame. This requirement is directly related to two specific aspects of the legal regime of the sector. On the one hand, the obligation to be technical director on pharmacy continuously and exclusively assumes the appointment of pharmacist that replace in their absences and impediments, particularly during the holidays, the pharmacy must have at least two pharmacists. On the other hand, the opening hours of pharmacies assumes the permanence of at least 7 a pharmacist 55 hours a week, which will only be possible with a minimum of two pharmacists. 6. it is also noteworthy that the present law continues to provide for the assignment of new pharmacies through public tender. The licensing regulation will be subject to own diploma, which will adapt the rules of capitation and distance to the needs of users in accessibility to medicine. The licensing requirements will also be modified, depending on the subjective change of the Pharmacy and the promoting of fair and equitable sharing of permits, based on less ownership of establishments by competitor, within the limit of four pharmacies. The new scheme highlights the possibility of transfer of pharmacies within the same municipality, regardless of licensing and pubic contest, due to the principle of freedom of installation. 7. This decree-law does not alter the list of goods to be supplied to the public by pharmacies, only clarifies and updates the terminology used. As regards the exemption of medicines, the new legal regime allows the pharmacies – and, in the case of non-prescription medicines, also the places of sale of these medicines – dispensing with us over the Internet and at home. These new forms of relationship of pharmacies with the mailers were thought especially for situations of people unable to move. Although the genesis of these innovative possibilities for exemption was not provided for, any restriction on the imposition of an additional value for the provision of these services. Still with regard to products for sale in pharmacies, opens the possibility of these purchasing drugs through tender, expressly prohibited in legislation now repealed and that, for reasons of consistency, is not any reflection on new legislation. 8. This decree-law, assumes a special relevance to the pharmacies providing pharmaceutical services, whose definition it is up to the Government. Therefore, allows that the pharmacies, dispensing medications, perform other functions of relevant public interest in promoting the health and well-being of users. 8 9. It is clear throughout the Ordinance, the concern with the quality of the services provided by pharmacies, considering that this is an activity whose public interest assumes greater relevance justifies expressed legislative forecast. To ensure the effective and efficient follow-up of irregular situations, including legally established standards or the contrary of deficient provision of services, as well as offences conduct, the decree-law establishes the obligation of the pharmacies have books of complaints. On this issue, the new decree-law adds an innovation, to establish the possibility of users claim in a given area of a website, specific to these situations. 10. the provisions on penalties applicable are an important modification of the relationship of pharmacies with the State, in the absence of any specific crime. It is not a true decriminalization, but only the recognition of the sufficiency of the current penal law in predicting the types of unlawful criminal relevance pipeline Integrator arising from breach of this decree-law. At the same time, the new scheme will provide a panoply of mere social ordering illegal, applicable to natural and legal persons, expressing the idea of warning and social censorship, through which the Administration claims the will to protect the public interest and assumes the responsibility of the respective application. 11. Another aspect to highlight in this diploma is reflected in collaboration between INFARMED and order of Pharmacists in the supervision of drug law offences, assuming the administrative entity the duty to communicate that the public association the behaviors that do not comply with the rules of ethical nature. Were heard, on an optional basis, the order of pharmacists, the National Association of pharmacies, the pharmacy Association of Portugal, the Portuguese Association of the graduates in Pharmacy and the National Union of pharmacists.
So: the use of legislative authorization granted by law no _ _ _/_ _ _ _ _ _, in accordance with point (b)) of paragraph 1 of article 198 of the Constitution, the Government decrees the following: 9 Chapter I General provisions Article 1 subject-matter this Decree-Law establishes the legal regime of pharmacies.
Article 2 public interest
The pharmacies are continuing health and activity of pubic interest and ensure the continuity of the services they provide to users.
Article 3 freedom of installation must be respected the principle of freedom of installation of pharmacies, since observed the requirements legally provided for.
Article 4 free choice 1-users have the right to free choice of pharmacy. 2-The health services or institutions, public or private, as well as health care professionals prescribers of drugs, cannot interfere in the choice of users, being denied to them, namely, pipe or drum up clients to any pharmacy.
10 article 5 principle of equality the relationship of pharmacies with users obeys the principle of equality.
Article 6 Duty 1 medicines waiver-pharmacies have a duty to dispense drugs, legally laid down conditions, except as provided in the following paragraph. 2-The prescription drugs can only be dispensed to users that submit, except in cases of force majeure, duly justified.
Article 7 duty to pharmacovigilance pharmacies collaborate with INFARMED on the identification, quantification, evaluation and prevention of the risks of using medications, once marketed, enabling the follow-up of possible adverse reactions.
Article 8 1 rational use of medicines-pharmacies promote the rational use of medicines. 2-pharmacies offer users information about the price of the medicinal product essentially similar medicinal products requested.
Article 9 places of dispensation of drugs exemption of medicines to the public can only be carried out: a) For pharmacies, on its premises, at home or via the Internet; b) by locals to sell non-prescription medicines, on its premises, at home or over the Internet. 11 article 10 accessibility to disabled citizens The pharmacies must have conditions that allow access of disabled citizens at their facilities.
Article 11 confidentiality Duty 1-people working in pharmacies are obliged to keep secret the fact that they have knowledge by reason of their activity. 2-the duty of confidentiality ceases when the disclosure is necessary to safeguard sensitive interest superiority.
Article 12 Obligation of cooperation 1-The pharmacies collaborate with Governments in the formulation and implementation of drug policy, in particular in the campaigns and health promotion programs and defense is the cause of public health. 2-pharmacies communicate to INFARMED-National Authority of Medicine and health products, i. p. (INFARMED), drug units dispensed and its selling price to the public. 3-the duty of collaboration should ensure respect for users ' personal data, in particular those relating to the privacy of private life.
Article 13 Service Quality pharmacies implement and maintain a quality management system aimed at continuous improvement of the services they provide to users.
12 Chapter II ownership Regime article 14 1 pharmacies-property can be owners of pharmacies individuals or companies. 2-commercial societies in which social capital is represented by shares these are obligatorily nominative. 3-The social economy sector entities may be owners of pharmacies provided they comply with the provisions of this decree-law and other rules that the implement, as well as the tax regime applicable to legal persons referred to in paragraph 1.
Article 15 Limits 1-Any person or company may hold or exercise, simultaneously, directly or indirectly, ownership, exploitation or management of more than four pharmacies. 2-To the limit referred to in the preceding paragraph are not considered concessions of pharmacies from dispensing medicines to the public hospitals of the national health service.
Article 16 Incompatibilities may not keep or exercise, directly or indirectly, ownership, exploitation or management of pharmacies: a) healthcare-prescribers of medications; b) representative associations of pharmacies, wholesale distribution companies medicines or pharmaceutical companies, or their employees; c) wholesale drug distribution companies; 13 d) pharmaceutical industry; and) private companies providing health care; f) subsystems that they in the price of medicines.
Article 17 property, farm or indirect management considered that a person owns the property, exploitation or the indirect management of a pharmacy when it owned, operated or managed:) By other persons or entities, in their own name or oblivious, but on account of that, namely business management or contract of mandate; b) by companies who are in a dominant position over the latter nor of the group.
Article 18 Sale, goodwill, letting and sale of exploration 1-pharmacies may not be sold, leased or pierced nor their exploitation be provided earlier than five years from the date of its opening, following an open competition. 2-Are excluded from the provisions of the preceding paragraph the duly justified situations before INFARMED. 3-are considered proper reasons, namely: a) the death of owner; (b)) the inability of the owner; c) the sharing of assets for divorce or legal separation of the owner; d) the Declaration of insolvency of the owner. 4-sale, goodwill, leasing and operating leasing shall comply in writing. 5-The legal transactions referred to in the preceding paragraph are reported to the INFARMED by the grantor or his attorney referred to in the Charter, within 30 days of the date of its celebration, for the purpose of endorsement on the licence.
14 article 19 companies and holdings the grantor referred to in planning communicates to INFARMED, within 30 days, for the purpose of endorsement on the licence, the following situations: a) Dissolution, merger or the transformation of commercial company owned pharmacy; b) transmission of shares, quotas or shares of commercial company owned pharmacy, including the acts affecting the ownership of the shares; c) Constitution, amendment or termination of burden that fall on the pharmacy.
Chapter III technical Direction article 20 Technical Director 1-the technical direction of the pharmacy shall be ensured, in permanence and exclusivity for pharmaceutical technical director, without prejudice to the provisions of paragraph 3 of this article. 2-the technical director is independent, technically and ethically, in the exercise of their functions, the owner of the pharmacy, without prejudice to situations of identity between the property and the technical direction of the pharmacy. 3-Must be designated by the owner of the pharmacy, and registered with the INFARMED, pharmacist, or pharmacists, which replace the technical director in their absences and impediments. 4-the designation referred to in paragraph 1 must precede the opening to the public of the pharmacy. 5-the owner must ensure the veracity of the entry in the stock records referred to in paragraph 3, stating the respective amendments INFARMED a 90 days in advance, except in cases of force majeure, duly justified.
15 article 21 1 technical director's duties-it is, in particular, to technical director: a) take responsibility for acts practiced in pharmaceutical pharmacy; b) ensure the provision of clarification to users about the use of medicines; c) Promote the rational use of medicines; d) ensure that the prescription is given only to users that do not present in cases of force majeure, duly justified; and Keep medicines and other) products supplied in good condition; f) ensure that the pharmacy is in proper conditions of health and safety; g) ensure that the Pharmacy has a sufficient supply of medicines; h) to ensure that the personnel working at the pharmacy, at all times, the cleanliness and hygiene; I) Verify compliance with the rules governing professional ethics and conduct of pharmaceutical activities; j) ensure compliance with the principles and duties provided for in this decree-law and in other regulatory legislation of pharmaceutical activity. 2-the technical director may be assisted by pharmacists and by properly enabled, under his direction and responsibility.
Article 22 Termination 1-the termination of the technical director shall be communicated, by the owner of the pharmacy, to INFARMED, with 90 days ' notice, except in cases of force majeure, duly justified. 2-at the same time as the communication referred to in the preceding paragraph, it shall be stated pharmacist who carries out the functions of technical director of pharmacy.
16 Chapter IV article 23 Personal Picture 1 pharmacist-pharmacies have, at least, of a technical director and another pharmacist. 2-in case of transformation of pharmacists, pharmacies can, for two years, have only a technical director. 3-pharmacists must tend to constitute the majority of the employees of the pharmacy.
Article 24 non-pharmacist Framework
Pharmacists can be assisted by pharmacy technicians or by another legally qualified staff.
Chapter V pharmacy opening to the public article 25 licensing and license 1-the licensing of new pharmacies is preceded by public tender. 2-pharmacies may only open to the public after being assigned the relevant permit, issued by INFARMED. 3-the change of ownership or transfer of the location of the pharmacy depends on endorsement on the licence.
17 article 26 Transfer the owner may, within the same municipality, transferring the location of the pharmacy, since note operating conditions.
Chapter VI operation of Pharmacy article 27 designation of Pharmacy-1 it is prohibited to use, in the name of pharmacy, any misleading or words constituting unfair competition. 2-the name of the pharmacy depends on INFARMED's approval. 3-the term "Pharmacy", simple or compound, and the symbol "Green Cross" may be used to identify pharmacies, except where the law expressly allows. 4-setting the "Green Cross" is defined by INFARMED.
Article 28 Information 1-pharmacies shall publish, visibly, the relevant information in the relationship with the users, namely: a) the name of the technical director; b) hours; c) pharmacies of turn in the municipality; d) grant discounts on the price of medicines; and reimbursement of) the State reimbursement of the price of medicinal products; f) book of complaints. 2-outside of pharmacies is inscribed the word "Pharmacy" or the symbol "Green Cross". 18 3-When the pharmacy's turn, the word "Pharmacy" or the symbol "Green Cross", should, whenever possible, be illuminated at night.
Article 29-1 Facilities pharmacies shall have appropriate facilities to ensure:) the safety, conservation and preparation of medicines; b) accessibility, convenience and privacy of users. 2-for the purposes of the preceding paragraph, the pharmacies must have, in particular, of the following divisions: the) customer service; b) storage; c) laboratory; d) sanitary facilities. 3-minimum areas of pharmacies and of each of the divisions referred to in the preceding paragraph are defined by INFARMED.
Article 30 hours of operation the hours of operation of pharmacies covers the operating periods, daily and weekly, and the permanent service shifts of reinforcement scheme and availability, regulated regime in own diploma.
Article 31 compulsory Eviction the personnel that performs functions in the pharmacy, including technical director, other pharmacists and pharmacy technicians, are away from their place of work when hit by diseases compulsory eviction, in the same terms on which allows the temporary departure of school attendance and other activities undertaken in the establishments of education and teaching to the students , teaching and non-teaching staff. 19 article 32 Identification staff who performs functions of public service in pharmacies should be properly identified, through the use of a card, containing the name and professional title.
Article 33 products authorized pharmacies can provide to the public: a) Medicines; b) medicinal substances; c) Medicines and veterinary products; d) Medicines and homeopathic products; e) natural products; f) medical devices; g) dietary supplements and nutritional products; h) plant protection products; I) cosmetic and personal hygiene products; j) childcare articles; l) comfort products.
Article 34 conservation and shelf life-1 at pharmacies cannot exist in a poor state of conservation products. 2-pharmacies cannot deliver products that exceed the period of validity.
Article 35 Medicines sold out 1-pharmacies must provide, with the as soon as possible, by getting the 20 requested medicines which are sold out. 2-the exemption of medicines obtained in accordance with the provisions of the preceding paragraph is guaranteed not to cause any additional payment.
Article 36 pharmacies pharmaceutical services can provide pharmaceutical services to promote the health and well-being of users.
Article 37 Documents pharmacies have their premises: a) Portuguese Pharmacopoeia, paper edition, in electronic form or online, from Web site recognized by INFARMED; (b)) other documents indicated by INFARMED.
Article 38 Complaints 1-pharmacies have complaints book. 2-pharmacies send monthly to INFARMED copy of complaints made by users. 3-INFARMED offers, on its website, an area destined to the complaints of users.
Chapter VII closure of Pharmacy article 39 Communication except in cases of force majeure, duly justified, pharmacies may only terminate 21 following the communication to INFARMED, with 90 days ' notice.
Article 40-1 in operation if the closure is seriously harmful to the public interest, INFARMED provides for maintenance of a pharmacy in operation to ensure users ' accessibility to waiver of medicines. 2-for the purposes of the preceding paragraph, INFARMED can, namely: to notify the owner to maintain) the pharmacy operation, with the pain of expiry of the licence; b) Assign the provisional exploration of a pharmacy to a pharmacist, if the owner does not ensure the maintenance of the pharmacy operation. 3-the role of the provisional operating a pharmacy determines the immediate opening of tender for the licensing of new pharmacy and ceases with the assignment of the new Charter.
Article 41 Reopening 1-without prejudice to the provisions of the previous article, the pharmacy after work for the minimum period of one year, is voluntarily closed can reopen, without further formalities, within one year from the date of termination, provided that this fact is communicated to INFARMED, with the advance of 30 days. 2-the right to reopen the pharmacy 60 days after notification of the owner to do so, with the pain of this right expires by opening new public competition and the resulting termination of its Charter.
Article 42 Closing 1-pharmacies, pharmacists and pharmaceutical jobs permanent furniture can be terminated by INFARMED when not meet the opening requirements and operation. 22 2-If the non-compliance referred to in the preceding paragraph do not affect public health and the trust of clients, the closure can be temporary and limited to the period necessary for the correction of non-conformities detected. 3-If the owner does not terminate the pharmacy after the obligation to practise such an act to be notified, INFARMED executes it by force, leaving the expenditure on the thanks.
Chapter VIII pharmaceutical article 43 Posts Posts 1-permanent pharmaceutical can be transformed into pharmacies pharmaceutical jobs that fulfil the conditions of operation. 2-the opening of pharmacies in accordance with the preceding paragraph depends on prior allocation of permits.
Article 44 1-mobile Each pharmaceutical Jobs pharmacy may hold two posts pharmacists furniture. 2-The pharmaceutical mobile stations are subject to the pharmacy licence endorsement which it concerns. 3-opening pharmaceutical jobs depends on INFARMED's clearance furniture. 4-INFARMED defines, for each post mobile, their pharmacist geographical area of action. 5-operating requirements of pharmacists furniture is defined by INFARMED.
Chapter IX supplementary provisions article 45 Inspection 1 23-Safe determination to the contrary, the provisions of this Decree-Law fit to INFARMED. 2-INFARMED can request the assistance of other entities, including law enforcement officials, in the performance of supervisory functions. 3-INFARMED should collaborate with the order of pharmacists and the offences whose sanctions procedure is within its competence.
Article 46 The proprietary Agents of pharmacies are liable for breaches of contra-ordenacionalmente provided for in this chapter.
Article 47 Against serious offences
1-Constitutes a misdemeanour punishable, in the case of natural persons, from € 500 to € 5000 and, in the case of legal persons, with fines of € 5000 to 20000 €: a) the breach of the duty of pharmacovigilance laid down in article 7; b) the breach of the duty of information about the price provided for in paragraph 2 of article 8; c) the breach of the duty of cooperation provided for in article 12; d) failure in writing in legal transactions referred to in paragraph 4 of article 18; and communication), in accordance with paragraph 5 of article 18; f) the failure to comply with the obligation laid down in article 19; g) violation of the provisions of paragraphs 1 and 2 of article 22; h) using a non-approved designation, in violation of article 27; I) violating the reporting obligations provided for in article 28; j) the lack of facilities, rooms or access conditions provided for in paragraphs 1, 2 and 3 of article 29; 24 l) Breach of duty of identification provided for in article 32; m) violation of the provisions of article 37; n) the infringement of the provisions of article 39 2-Constitutes a misdemeanour punishable by a fine of € 5000 to € 20000,: a) the pharmacy belongs to legal person that does not take the form of commercial company; b) the companies actions owners of pharmacies are not registered.
Article 48 Against very serious offences Constitutes a misdemeanour punishable, in the case of natural persons, with fines of € 5000 to € 20000, and in the case of legal persons, with fines of € 20000 to 50000 €: a) the breach of the duty of dispensation of medicinal products provided for in article 6; b) the breach of the duty of confidentiality, laid down in article 11; c) keeping or exercising at the same time, directly or indirectly, from property, exploitation or management of more than four pharmacies, in violation of the provisions of article 15; d) the arrest or the exercise, directly or indirectly, from property, exploitation or the management of pharmacies by the persons or entities referred to in article 16; e) sale, goodwill, the lease or transfer of the operation of the pharmacy before after five years from the date of opening to the public in violation of the provisions of article 18; f) violation of the provisions of paragraph 1 of article 20; g) failure of technical director duties provided for in paragraph 1 of article 21; h) the existence of a pharmacist who does not comply with the provisions of article 23; I) the opening of the pharmacy to the public without the assignment of their Charter or the lack of endorsement in case of change of ownership or transfer of location, provided for in article 25; j) the provision to the public of unauthorized products, in violation of article 25 33; l) the existence, in pharmacies, in a poor state of conservation or providing drugs that exceed the period of validity, in violation of the provisions of article 34; m) the levying of extra payment for the exemption of medicines sold out, in violation of laid down in paragraph 2 of article 35; n) the lack of A complaints book, in violation of the provisions of article 38; the) the transformation of permanent pharmaceutical jobs in pharmacies in violation of the provisions of paragraph 2 of article 43, or who do not possess the respective operating conditions; p) pharmaceutical jobs opening furniture in violation of article 44 article 49 sanctions can be applied in parallel with the fines provided for in articles 47 and 48, the following penalties: the) loss of objects belonging to the agent; b) closure of the establishment; c) suspension of license; d) Deprivation of the right to participate in public tenders which have as their object the provision of public services or the assignment of licences or permits.
Article 50 Against-1-specific ordering health care professionals prescribers of drugs that interfere with the choice of users, in violation of the provisions of paragraph 2 of article 4, are punished with a fine of € 5000 to € 20000. 2-the establishments or private health services, to interfere in the choice of users, in violation of the provisions of paragraph 2 of article 4, are punished with a fine of € 20000 to 50000 euros. 26 article 51 administrative offences processing Processing and the application of the fines under the INFARMED.
Article 52 1-Nullity are null the legal transactions concluded against the provisions of this Ordinance or producing or capable of producing, a practical effect identical to what the law meant to prohibit. 2-Pubic Ministry shall, on their own initiative or following the initiative of INFARMED, propose actions for voidness and apply the measures that the case will fit to prevent legal transactions concluded in breach or fraud to the law to take effect.
Article 53 Notaries notaries must communicate to INFARMED all legal transactions that involve, directly or indirectly, in whole or in part, the change of ownership, operation or management of a pharmacy.
Chapter X transitional provisions article 54 a transitional Standard 1-formal transformation of posts permanent pharmaceutical in pharmacies can occur within a year. 2-permanent pharmaceutical jobs not become pharmacies in 27 deadline referred to in the preceding paragraph are closed.
Article 55 Transitional Standard material to public tenders for the licensing of pharmacies shall apply the legislation in force at the time of its opening.
Chapter XI final provisions article 56 Regulations the Member of Government responsible for regulating health, by order, within 120 days after the entry into force of this Decree-Law: a) the form of communication to INFARMED of the obligations provided for in this Decree-Law; b) conditions and requirements of the exemption of medicines at home and over the Internet; c) the licensing of pharmacies and procedure of allocation of permits; d) the definition of pharmaceutical services that can be provided by pharmacies; and) the procedure and the requirements for planning the pharmacies that result from the processing of pharmaceutical jobs.
Article 57 private social solidarity Institutions pharmacies which, at the date of entry into force of this decree-law, are property of private social solidarity institutions, and while they do not have to comply with the requirements laid down in article 14 of this Decree-Law 28 article 58 website INFARMED ensures, on its Internet Web site, an area destined to communications of pharmacies , in particular those laid down in articles 8, 12, 18 to 20, 22, 31, 38, 39 and 41 article 59 Standard set-1 following diplomas are hereby repealed: the) Law No. 2125, of 20 March 1965; b) Decree-Law No. 48547, August 27 1968. 2-references in legislation or regulation repealed standards in the preceding paragraph shall be deemed to be made to the relevant standards in force.
Article 60 entry into force this law shall enter into force 60 days after its publication.
Seen and approved by the Council of Ministers of the Prime Minister, the Minister of justice the Minister of labour and Social solidarity Minister of health
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