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Law No. 81 Of 9 May 1997 On The Profession Of Pharmacist, Establishment, Organization And Functioning Of The College Of Pharmacists In Romania

Original Language Title:  LEGE nr. 81 din 9 mai 1997 privind exercitarea profesiunii de farmacist, înfiinţarea, organizarea şi funcţionarea Colegiului Farmaciştilor din România

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LEGE no. 81 81 of 9 May 1997 on the exercise of the profession of pharmacist, establishment, organization and functioning of the Romanian College of Pharmacists
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 89 89 of 14 May 1997



The Romanian Parliament adopts this law + Chapter 1 Exercise of the profession of pharmacist + Section 1 General provisions + Article 1 The exercise of the profession of pharmacist is a right of any natural person, Romanian citizen, owner of the pharmacist diploma, issued by a university educational institution with pharmaceutical profile, accredited, from Romania or from abroad, equated according to law. The exercise of the pharmacy profession is endorsed by the Romanian College of Pharmacists and authorized by the Ministry of Health. + Article 2 The pharmacy profession aims to ensure public health, through the research, production, dissemination and release of medicines under the quality conditions provided by the Romanian Pharmacopoeia and other official standards in the country and abroad, approved by the Health Ministry. + Article 3 (1) In the exercise of the profession, the pharmacist must prove devotion, correctness, availability and respect for the person who is addressed for the procurement of the necessary medicines. (2) In the activity of preparation and release of medicines, having their full responsibility, the pharmacist has the right of decision. (3) At the graduation of the educational institution, the pharmacist will submit the following oath: " In my entire activity I will show a deeply human attitude towards man and collectivity. I will respect the dignity and personality of the patient, exercising the profession with conscientiousness, respecting the norms of ethics and pharmaceutical deontology. I will be fair to myself and to my brethren, to whom I will ask for collaboration, and I will not refuse to give them support, when I am asked, in the interest of the sick. I will not accept under any reason that my work as a pharmacist should be used against human health and life. I will be patient and understanding of the one who, due to the disease, does not give me due respect. I swear, on honor, solemnly and freely! " (4) The profession of pharmacist is a liberal profession. The pharmacist is not a public servant. + Article 4 (1) The profession of pharmacist may be exercised by the one who fulfils the following conditions: a) is a Romanian citizen, residing in Romania; b) is licensed of a university educational institution with pharmaceutical profile, under the law; c) is not found in any of the cases of undignity provided by this law; d) is medically fit for the exercise of the profession. (2) The profession of pharmacist can be exercised in Romania and by pharmacists foreign citizens, under the conditions provided by this law and on the basis of reciprocity, established by conventions to which Romania is a party. + Section 2 Incompatibilities and prohibitions + Article 5 Cannot exercise the profession of pharmacist: a) the pharmacist who was definitively convicted by court decision, even if he was rehabilitated, for the intentional commission of a crime against humanity or life, in circumstances related to the exercise of the profession of pharmacist; b) the pharmacist to whom the punishment of the prohibition to exercise the profession has been applied, for the duration established by final or disciplinary court decision. + Article 6 (1) The exercise of the profession of pharmacist is incompatible with: a) the dissemination and marketing of other products outside those registered and approved by the Ministry of Health; b) the profession of doctor; c) any profession or occupation likely to prejudice the dignity of the profession of pharmacist or good morals. (2) The profession of pharmacist cannot be exercised by a person, if it has been found that its health is inadequate, being attested, as such, by medical certificate issued by the Commission of medical expertise and recovery of work capacity, according to the law. + Section 3 Authorization for the free practice of the profession of pharmacist + Article 7 (1) The exercise of the profession of pharmacist is made on the basis of the authorization of free practice, issued by the Ministry of Health within 30 days from the submission of documents. (2) The authorization of free practice of the profession of pharmacist shall be granted on the basis of the following documents: a) diploma issued by a university educational institution with pharmaceutical profile, accredited under the law; b) certificate of criminal record; c) health certificate; d) opinion of the Romanian College of Pharmacists. + Article 8 (1) Pharmaceutical activities concerning the preparation, release, control and preservation of pharmaceutical products and substances in pharmacies and laboratories are conducted and supervised by pharmacists. In hospital pharmacies, the pharmacist releases drugs only for hospital wards. (2) In the pharmaceutical industry and in drug stores, the pharmacist supervises the specific processes of preparation, control, release and preservation of pharmaceuticals. (3) In pharmacies, the release of medicinal products, on prescription, is done only under the supervision of the pharmacist. + Article 9 (1) Pharmacists who have the right to a pension for their work and age limit, according to the law, can be kept, on request, in professional activity, with the opinion of the Romanian College of Pharmacists, until the age of 60 women and 65 years men, with the exception of those who have the doctorate and whose activity can be extended until the age of 65 women and 70 years old men. (2) Pharmacists who have exceeded the ages provided in par. (1) may continue to practise, on request, with authorization of free practice granted annually, under the conditions of art. 7 of this law, only in the private sector. + Article 10 The control and supervision of the pharmacy profession is carried out by the College of Pharmacists in Romania and by the Ministry of Health, under the law. + Chapter 2 Establishment, organization and functioning of the Romanian College of Pharmacists + Section 1 General characteristics + Article 11 (1) The Romanian College of Pharmacists is established as a professional, non-governmental organization, with legal personality, apolitical and non-patrimonial, which represents the interests of the profession of pharmacist, ensures the protection and preservation the prestige of this profession within the social life. (2) The Romanian College of Pharmacists has institutional autonomy and exercises its powers without the possibility of interference. (3) The Romanian College of Pharmacists includes all pharmacists, Romanian citizens, domiciled in Romania, authorized to practice the profession of pharmacist. Pharmacists who, on the date of entry into force of this law, are authorized and operate in units of the Ministry of Health or other ministries with their own health and pharmaceutical network, as well as in the private sector, are members of the Romanian College of Pharmacists from this date. (4) The head office of the Romanian College of Pharmacists is in Bucharest. + Section 2 Duties of the Romanian College of Pharmacists + Article 12 The Romanian College of Pharmacists has the following tasks: a) defend the dignity and promote the rights and interests of its members; defend the honor, freedom and professional independence of the pharmacist in the exercise of the profession; ensure the pharmacists ' compliance with their obligations; b) elaborates, adopts and supervises the application of its own status and the Code of Pharmaceutical De c) endorse the issuance of the authorization of free practice; d) supports the activity and development of pharmaceutical scientific research and can organize scientific manifestations; e) represent its members in relations with the institutions, scientific associations and trade unions; f) collaborates with the Ministry of Health to train, specialize and improve the professional training of pharmacists; g) elaborates, in collaboration with the Ministry of Health, the methodology for granting the professional degree and the competition theme; h) proposes and establishes, together with the Ministry of Health, the principles on territorialization and the establishment of new pharmacies, laboratories and pharmaceutical warehouses; i) grant scholarships for specialisation in the pharmaceutical sciences; j) inform its members of scientific news and organize, for this purpose, an information center and professional publications; k) judge deviations from the norms of professional ethics and pharmaceutical deontology; l) establish and support institutions and actions of provision and medical-social assistance for pharmacists and their families; m) collaborates with similar organizations in other countries. + Section 3 Members of the Romanian College of Pharmacists. Rights and obligations + Article 13 (1) The members of the Romanian College of Pharmacists are registered in a register, which is published periodically. (2) Retired pharmacists, on the date of entry into force of this law, can register in the Romanian College of Pharmacists. + Article 14 The members of the Romanian College of Pharmacists are obliged: a) comply with the regulations in force regarding the exercise of the profession of pharmacist; b) comply with and apply the rules of good pharmaceutical practice; c) to promptly grant emergency pharmaceutical assistance, as a fundamental, professional and civic duty; d) not to prejudice the interests of the patient; e) comply with the Statute of the Romanian College of Pharmacists; f) to be concerned with the improvement of professional qualification; g) to keep the secret of the pharmacy profession, according to the law. + Article 15 The incomes of the Romanian College of Pharmacists are: a) the registration fee, the monthly contributions of the members, other funds resulting from cultural and scientific events; b) donations, related, sponsorships and editorial rights, under the law; c) other sources. + Article 16 Money funds can be used for: administration expenses; staff salaries; purchase of fixed assets, household material; financing of organizational expenses; improvement of professional training; granting of scholarships, through competition, pharmacists; the help of low-income pharmacists and their families; the creation of institutions with philanthropic and scientific purpose and others, which are established by the National Council of the Romanian College of Pharmacists. + Section 4 Organisation and operation + Article 17 The Romanian College of Pharmacists is organized at national and county level, respectively of Bucharest. + Article 18 The governing forums of the Romanian College of Pharmacists, at the county level or of Bucharest, are: the general meeting, the county council, respectively of the city of Bucharest, and the steering committee. + Article 19 The Romanian College of Pharmacists will work with the Ministry of Health in developing specific normative acts. + Article 20 (1) The individual employment contract of the person exercising a leading position in the steering committee of the county council, respectively of the city of Bucharest, and in the National Council of the Romanian College of Pharmacists shall be suspended, at the request of the person concerned, while he performs that function, with the maintenance of the job. (2) The person in a situation referred to in par. (1) benefit from seniority, the period being thus considered. + Article 21 (1) For the first elections, the county council or the city of Bucharest, as the case may be, shall have a number of members in proportion to the number of pharmacists registered, elected by the general assembly, as follows: -up to 100 pharmacists registered in register 7 members -between 101 and 500 pharmacists registered in the register 11 members -between 501 and 1,000 pharmacists enrolled in register 13 members -between 1,001 and 2,000 pharmacists registered in the register 19 members -more than 2,000 pharmacists registered in the register 21 members. (2) The county council or of the city of Bucharest, as the case may be, has a number of 3-11 alternates, elected by the general assembly. + Article 22 (1) The county council, respectively of the city of Bucharest, will elect among its members a steering committee consisting of the president, three vice presidents and a secretary. (2) The functions of the President, Vice-President and Secretary are incompatible with: a) the corresponding function in a professional trade b) the position of director and deputy director of a pharmaceutical company established by Government Decision no. 15/1991 on the establishment of pharmaceutical companies-S.A.; c) leadership function in the structure of the Ministry of Health (minister, secretary of state, department head, general manager, deputy director general, director and deputy director). + Article 23 (1) The members of the county council, respectively of the council of Bucharest, holders and alternates, are elected for a maximum period of 2 years. (2) The choice of members shall be made by secret ballot, by simple majority, by the participation of at least half plus one of the total number of registered pharmacists. If the proportion of half plus one of the total number of pharmacists is not achieved, other elections will be held after two weeks, in the presence of the simple majority of number of members present + Article 24 (1) The county council, respectively of the city of Bucharest, meets at the convocation of the president, in ordinary meetings, every two months. Exceptionally, at the request of one third of its members, the county council, respectively of the city of Bucharest, can be convened in extraordinary meetings. (2) The decisions of the county council, respectively of the city of Bucharest, shall be adopted by the vote of half plus one of the total number + Article 25 (1) The county council, respectively of the city of Bucharest, exercises the powers provided by law, given in its competence, at the level of the county or city of Bucharest, by the operating regulation adopted by the general assembly of the Pharmacists in Romania. (2) In order to exercise their duties, the county council, respectively of the city of Bucharest, operates in commissions, chosen by the respective general assembly, by fields of activity or on pharmaceutical specialties, in accordance with the operating regulation adopted by the general assembly of the Romanian College of Pharmacists. + Article 26 The management of the Romanian College of Pharmacists, at national level, is exercised by: a) general meeting; b) the national council; c) the steering committee. + Article 27 (1) The General Assembly of the Romanian College of Pharmacists is composed of representatives elected by the general assembly from each county and from Bucharest, by direct and secret ballot. The norm of representation is 1 to 50. (2) The General Assembly of the Romanian College of Pharmacists meets annually. + Article 28 The General Assembly adopts the Code of Pharmaceutical Deontology and the Regulation on the organization and functioning of the Romanian College of Pharmacists, in the presence of at least half plus one of the elected representatives. + Article 29 The Romanian College of Pharmacists, between the sessions of the general assembly, is headed by the national council + Article 30 (1) The National Council of the Romanian College of Pharmacists is composed of one representative of each county, three representatives of the city of Bucharest and one representative of the pharmacists from each ministry who has a health network Own. Apart from these, the National Council of the Romanian College of Pharmacists can be assisted, with an advisory role, by a representative of the Academy of Medical Sciences, the Ministry of Health, the Ministry of Labour and Social Protection and the Justice Ministry. (2) For the establishment of the National Council of the College of Pharmacists in Romania, the presence of at least half plus one of the number of representatives established in par. ((1). + Article 31 The decisions of the National Council of the Romanian College of Pharmacists are adopted by voting at least half plus one of the total number of members. + Article 32 The tasks of the Romanian College of Pharmacists are: a) elaborates the Code of pharmaceutical deontology, the statute, as well as the Regulation on the organization and functioning of the Romanian College of Pharmacists, within 6 months from the constitution of the national council; b) fix the fee to be paid by each pharmacist to the county council or the city of Bucharest, as the case may be, establishing the share of this fee, which must be transferred to the national council; c) manages the assets of the Romanian College of Pharmacists and can create and subsidize actions interested in the pharmaceutical profession, relief or sponsorship actions; d) control the management of the county council, respectively of the city of Bucharest, which must inform it about all financial actions; e) settle, within 30 days from the registration, as the superior court, the appeals made against the decisions given by the county councils, respectively of the city of Bucharest, in accordance with its own regulations. + Article 33 Within the National Council of the Romanian College of Pharmacists, several commissions operate, the number of which are established by their own regulations. + Article 34 (1) The Board of Directors of the Romanian College of Pharmacists shall ensure its permanent activity, in accordance with the law and its own regulations. (. The Steering Committee shall be composed of a President, three Vice-Presidents and one Secretary-General, elected by the National Council. + Section 5-a Procedures and sanctions + Article 35 The College of Pharmacists in Romania resolves the disputes and deontological and disciplinary deviations of the pharmacists. + Article 36 (1) The members of the Romanian College of Pharmacists, who violate the sworn oath, the specific laws and regulations on the exercise of the profession of pharmacist and who do not comply with the Code of pharmaceutical deontology, the gravity of the deviation, and are liable to one of the following sanctions: a) reprimand; b) warning; c) vote of blame; d) temporary suspension, for a period of 6-12 months, of the membership of the Romanian College of Pharmacists; e) withdrawal of the membership of the Romanian College of Pharmacists. (2) The sanctions provided in par. ((1) lit. a)-c) shall be applied by the county council, respectively of the city of Bucharest, for their members. (3) The sanctions provided in par. ((1) lit. d) and e) shall be applied by the National Council of the Romanian College of Pharmacists. (4) The conclusions of the investigation and the sanctions applied shall be communicated within 24 hours, necessarily, to the Ministry of Health and to the legal person with whom the sanctioned pharmacist has concluded the individual employment contract and who decide, as the case may be, on the basis to them, on the opinion of free practice of the profession of pharmacist, as well as on the individual employment contract. + Article 37 (1) Against the sanctions provided for in art. 36 36 para. ((1) lit. a)-c) an appeal may be brought to the competent deontological commission, within 30 days from the communication of the sanction. (2) Against the sanctions provided for in art. 36 36 para. ((1) lit. d) and e) it can be appealed to the court within which the sanctioned pharmacist carries out his activity, within 30 days from the communication of the sanction. + Article 38 The disciplinary liability of the members of the Romanian College of Pharmacists, according to this law, does not exclude criminal, contravention, civil or material liability, according to the law. + Article 39 After a period of 6 months after the decision to suspend the authorisation of free pharmaceutical practice is issued, the pharmacist concerned may request a review of the decision. In case of rejection, a new application can only be made after 6 months. + Article 40 Practicing the profession of pharmacist by a person who does not have this quality constitutes a crime and is punished according to the criminal law. + Chapter 3 Final and transitional provisions + Article 41 The Ministry of Health has the obligation to provide the designated electoral commissions for the organization of the College of Pharmacists in Romania the nominal record of pharmacists in Romania, according to the annex to this law, within 30 days of to its publication in the Official Gazette of Romania. + Article 42 (1) Until the election of the first county council of the Romanian College of Pharmacists, respectively of the city of Bucharest, the applications for registration in the college shall be submitted to the respective electoral commissions, following that, within 6 months from the same date, Ministry of Health to issue authorization for free pharmaceutical practice. (2) The first elections will be held by the designated electoral commissions, in which the territorial pharmaceutical companies and the city of Bucharest, on the one hand, and the county branches of the pharmaceutical trade unions, existing on the date of entry in the vigor of this law, on the other hand, have an equal number of representatives. The electoral commissions are made up of six members. (3) A central electoral commission will be organized at the level of the country, in which the Ministry of Health will have three representatives, the pharmacists ' unions, as a whole, three representatives and ministries with their own health network, one representative. The activity of this commission consists in the validation of the county elections and the organization of elections on the country; its activity ceases with the legal constitution of the first general meeting of the Romanian College of Pharmacists + Article 43 The Annex forms an integral part of this Law + Article 44 This law shall enter into force within 30 days of its publication in the Official Gazette of Romania. + Article 45 On the date of entry into force of this Law, any contrary provisions shall be repealed. This law was adopted by the Chamber of Deputies at its meeting on April 14, 1997, in compliance with the provisions of 74 74 para. (1) of the Romanian Constitution. p. CHAMBER OF DEPUTIES PRESIDENT ANDREI IOAN CHILIMAN This law was adopted by the Senate at the meeting of 18 April 1997, in compliance with the provisions of art. 74 74 para. (1) of the Romanian Constitution. p. SENATE PRESIDENT MIRCEA IONESCU-QUINTUS + Annex 1 Name and surname of pharmacist ....................................... Date of birth ........................................................... Speciality and professional degree ..................................... Scientific title ....................................................... Promotion ................................................................ Job .......................................................... Address and telephone number ............................................ ------------------