81 of May 9, 1997 on the profession of pharmacist, establishment, organization and functioning of the College of Pharmacists in Romania
Official Gazette no. 89 of May 14, 1997
Romanian Parliament adopts this law.
practice of pharmacy
General Provisions Section 1
Practice of pharmacy is the right of any individual, Romanian citizen, owner of a pharmacist diploma, issued by an institution of higher education with pharmacological profile, accredited in Romania or abroad, equated the law. The practice of pharmacy is endorsed by the College of Pharmacists in Romania and authorized by the Ministry of Health.
Pharmacist profession aims to ensure public health by researching, producing, distributing and dispensing quality under Romanian Pharmacopoeia and other official standards in the country and abroad, approved by the Ministry of Health.
(1) In the practice, the pharmacist must prove devotion, fairness, availability, respect for the person it is addressed to procuring necessary medicines.
(2) The work of preparation and drug delivery, with full responsibility to their pharmacist has the right to decide.
(3) Upon completion of the educational institution, the pharmacist will take the following oath:
"In my entire activity will give evidence of a deeply human attitude towards man and the community.
I will respect the dignity and personality of the patient exercised profession conscientiously, respecting the rules of ethics and professional conduct pharmaceutical. I
be fair to myself and my colleagues, whom I ask for cooperation, and I will not refuse to support them, when I will be asked, in the interest of the patient.
I will not accept any reason that my work as a pharmacist to be used against human life and health.
I will be patient and understanding of one who, due to illness, do not give due respect.
I swear upon my honor, solemnly and free! "
(4) of the pharmacist profession is a liberal profession. The pharmacist is not a public servant.
(1) of the pharmacist profession can be exercised by the person who fulfills the following conditions:
A) is a Romanian citizen, residing in Romania;
B) is licensed by an institution of higher education with pharmacological profile, under the law;
C) is not in one of the cases of indignity provided by this law;
D) is apt, in terms of medical practice of the profession.
(2) the pharmacist profession can be exercised by pharmacists in Romania and foreign citizens, as provided by this law and on the basis of reciprocity established by conventions to which Romania is a party.
Incompatibilities and interdictions
There may exercise the profession of pharmacist:
A) pharmacist has been sentenced by court order, even if it was restored for the intentional commission of a crime against humanity or life circumstances related to the practice of pharmacy;
B) pharmacist to whom the penalty of prohibition to exercise the profession, over established by final judgment or disciplinary.
(1) Exercise pharmacist profession is incompatible with:
A) the dissemination and marketing of other products besides those registered and approved by the Ministry of Health;
B) the medical profession;
C) any profession or occupation of harming the dignity of the profession of pharmacist or morality.
(2) the pharmacist profession can not be exercised by a person if it was found that its health is inadequate and is certified as such by a medical certificate issued by the Commission of medical expertise and recovery capacity labor law.
authorization of free practice of the profession of pharmacy
(1) The exercise of the profession of pharmacy is based on the authorization of free practice, issued by the Ministry of Health within 30 days of the filing of documents.
(2) authorization of free practice of the profession of pharmacy is granted on the following instruments:
A) diploma issued by an institution of higher education with pharmacological profile, accredited under the law;
B) criminal record certificate;
C) health certificate;
D) the opinion of the College of Pharmacists of Romania.
(1) pharmaceutical activities on preparation, release, control and conservation products and pharmaceuticals in pharmacies and laboratories are directed and supervised by pharmacists. In hospital pharmacies, pharmacist, hospital wards only issue drugs.
(2) In the pharmaceutical industry, and storage of medicines, the pharmacist oversee specific processes of preparation, control, release and conservation products and pharmaceuticals.
(3) pharmacies, dispensing on prescription, is under the supervision of the pharmacist.
(1) Pharmacists who are entitled to pension for the work and the age limit by law can be maintained, upon request, in professional, endorsed by the College of Pharmacists in Romania, by the age of 60 years for women and 65 years for men, except those who have a doctorate and whose activity can be extended to 65 years for women and 70 years for men.
(2) Pharmacists who have passed ages in para. (1) can practice and, at his request, with free practice authorization granted annually under Art. 7 of this law only in the private sector.
Exercise control and supervision of the pharmacist profession is performed by College of Pharmacists in Romania and the Ministry of Health, under the law.
setting up, organization and functioning of the College of Pharmacists in Romania
(1) College of Pharmacists in Romania is established as a professional, governmental, legal personality, apolitical and non-profit organizations representing the interests of the pharmacist profession, ensure prosperity and preserve the prestige of this profession in social life.
(2) College of Pharmacists in Romania has institutional autonomy and exercise their responsibilities without any possibility of interference.
(3) College of Pharmacists in Romania includes all pharmacists, Romanian citizens residing in Romania, authorized to practice the profession of pharmacy. Pharmacists, on the date of entry into force of this Act, are authorized and operates in units of the Health Ministry and other ministries with sanitary network and pharmaceutical own and in the private sector are members of the College of Pharmacists in Romania at this date.
(4) The headquarters of the College of Pharmacists of Romania is Bucharest.
Powers of the College of Pharmacists in Romania
College of Pharmacists in Romania shall:
A) protect the dignity and promotes the rights and interests of its members; defend the honor, freedom and professional independence of pharmacists in the practice; ensure compliance by pharmacists obligations;
B) develop, adopt and oversee the application of its statutes and the Code of Ethics pharmaceutical;
C) approves authorization of free practice;
D) support and develop scientific research activity pharmaceutical and organize scientific meetings;
E) represents its members in dealing with institutions, scientific associations and trade unions;
F) collaborate with the Ministry of Health on training, specialization and professional training of pharmacists;
G) develop, in cooperation with the Ministry of Health, the methodology for granting professional degree and the contest theme;
H) proposes to establish, together with the Ministry of Health, the principles of territoriality and the establishment of new pharmacies, laboratories and pharmaceutical warehouses;
I) scholarships for specialization in pharmaceutical sciences;
J) inform Members on scientific novelties and organize this purpose, an information center and professional publications;
K) judge deviations from the rules of professional ethics and deontology pharmaceutical;
L) establish and support institutions and actions of social provision and medical assistance for pharmacists and their families;
M) collaborates with similar organizations in other countries.
members of the College of Pharmacists in Romania. Rights and obligations
(1) Members of the College of Pharmacists in Romania are enrolled in a registry, to be published periodically.
(2) Pharmacists retired after the entry into force of this law, can enroll in the College of Pharmacists in Romania.
Members of the College of Pharmacists in Romania shall:
A) comply with regulations regarding the practice of pharmacy;
B) to respect and apply the rules of good pharmaceutical practice;
C) pay promptly pharmaceutical emergency assistance as a fundamental duty, professional and civic life;
D) not prejudice the interests of the patient;
E) comply with the Statute of the College of Pharmacists in Romania;
F) be concerned with the improvement of professional qualification;
G) to the pharmacist profession secrecy law.
College of Pharmacists in Romania consist of:
A) fee, members' monthly contributions, funds resulting from other cultural and scientific;
B) donations, legacies, sponsorship and editorial rights under the law;
C) other sources.
The funds can be used for: administration expenses; staff salaries; purchase of fixed assets, materials household; financing organizational expenses; professional training; scholarships, competition, pharmacists; self help low-income pharmacists and their families; creating philanthropic and scientific institutions and others that are established by the National Council of the College of Pharmacists of Romania.
Structure and Functioning
College of Pharmacists in Romania is organized at national and county level, and for Bucharest.
Governing bodies of the College of Pharmacists in Romania, at county or Bucharest, are: the General Assembly, the county council, and in Bucharest, and the steering committee.
College of Pharmacists in Romania will cooperate with the Ministry of Health in developing specific normative acts.
(1) An individual employment contract of the person exercising a leadership steering committee of the county council, for Bucharest and the National Council of the College of Pharmacists of Romania shall be suspended at the request of the person concerned, the period how fulfills that function with continuous employment.
(2) persons in a situation referred to in para. (1) benefit from seniority, that period is thus considered.
(1) For the first election, the county council or municipality of Bucharest, respectively, has a number of members enrolled in proportion to the number of pharmacists obvious, elected by the General Meeting as follows:
- Up to 100 pharmacists registered in the register 7 members
- between 101 and 500 pharmacists registered in the register
11 members - between 501 and 1,000 pharmacists registered in the register
13 members - between 1,001 and 2,000 pharmacists registered in the register
19 members - over 2,000 pharmacists registered in the register 21 members.
(2) The County Council or Bucharest, where appropriate, 3-11 has a number of alternate members elected by the general assembly.
(1) The county council, respectively of Bucharest, will choose from among its members a steering committee consisting of the president, three vice-presidents and a secretary.
(2) The offices of president, vice president and secretary are incompatible with:
A) proper function of a professional union;
B) position of director and deputy director of a pharmaceutical company established by Government Decision no. 15/1991 on the establishment of pharmaceutical companies - SA;
C) the management position within the Ministry of Health (Minister, State Secretary, Head of Department, Director General, Deputy Director General, Director and Deputy Director).
(1) Members of the county council or board of Bucharest, and alternates are elected for a term not exceeding 2 years.
(2) Election of members shall be by secret ballot, a simple majority, the participation of at least half plus one of the total number of registered pharmacists. Will not be achieved if the proportion of half plus one of the total number of pharmacists for the leadership election of the county council or Bucharest will be organized after two weeks, other choices in the present simple majority of the members present.
(1) The County Council, and for Bucharest, shall be convened by the President, in ordinary meeting every two months. Exceptionally, at the request of one third of its members, the county council for Bucharest may be convened in extraordinary sessions.
(2) Decisions of the county and Bucharest Municipality shall be adopted by a vote of half plus one of the total membership.
(1) The County Council, and for Bucharest, duties prescribed by law within its jurisdiction in the county or Bucharest, the rules of procedure adopted by the general meeting of the College of Pharmacists in Romania.
(2) In the exercise of, the county council for Bucharest, working in committees, elected by the General Assembly that, on fields or pharmaceutical specialties in accordance with the operating rules adopted by the General Assembly College of Pharmacists in Romania.
Management College of Pharmacists in Romania, nationwide, is exercised by:
A) general assembly;
B) national council;
C) Steering Committee.
(1) The General Assembly of the College of Pharmacists of Romania is composed of representatives elected by the General Assembly in each county and in Bucharest, through direct and secret vote. The representation rate is 1 in 50.
(2) The General Assembly of the College of Pharmacists of Romania meets annually.
General Assembly adopt the Code of Ethics and Rules of pharmaceutical organization and functioning of the College of Pharmacists in Romania, in the presence of at least half plus one of the elected representatives.
College of Pharmacists of Romania, between sessions of the general assembly is led by the national council.
(1) National Council of the College of Pharmacists of Romania is composed of one representative of each county, three representatives of Bucharest and one representative of pharmacists in each ministry has its own health network. Apart from these, the National Council of the College of Pharmacists in Romania may be assisted in an advisory capacity, a representative of the Academy of Medical Sciences, Ministry of Health, Ministry of Labour and Social Protection and the Ministry of Justice.
(2) The establishment of the National Council of the College of Pharmacists in Romania is required the presence of at least half plus one of the representatives in par. (1).
Decisions of the National Council of the College of Pharmacists in Romania are adopted by a vote of at least half plus one of the total membership.
Powers of the National Council of the College of Pharmacists in Romania are:
A) develop the Code of Ethics pharmaceutical statute and Rules of organization and functioning of the College of Pharmacists in Romania, within 6 months of the establishment of the national council;
B) fixed fee to be paid by each county council pharmacist or Bucharest, where appropriate, setting share of this fee, to be disbursed by the national council;
C) College of Pharmacists of Romania asset manager and can create exciting action and to subsidize the pharmaceutical profession, providing aid or sponsorship;
D) controlling the management of the county council, and for Bucharest, which must inform him about all financial dealings;
E) settled within 30 days of registration, the superior court, appeals against decisions given by the county councils, and for Bucharest, in accordance with its regulations.
The National Council of the College of Pharmacists of Romania operates several committees, whose numbers are set by competent and that by their own regulations.
(1) The Steering Committee of the College of Pharmacists in Romania ensure its continuing work in accordance with the law and its regulations.
(2) The Executive Board consists of a Chairman, three Vice-Presidents and a General Secretary, elected by the national council.
procedures and sanctions
College of Pharmacists in Romania settles disputes and deviations of ethics and discipline of pharmacists.
(1) Members of the College of Pharmacists of Romania, who filed the oath violates laws and regulations specific to the profession of pharmacist and not complying with the Code of Ethics pharmaceutical liable to disciplinary action, depending on the seriousness of the offense and shall be liable to one following sanctions:
D) the temporary suspension on an interval of 6-12 months, the membership of the College of Pharmacists in Romania;
E) withdrawal of the College of Pharmacists of Romania.
(2) The sanctions provided in par. (1) a) -c) shall apply to the county council for Bucharest, for their members.
(3) The penalties provided in par. (1) d) and e) shall apply to the National Council of the College of Pharmacists of Romania.
(4) The conclusions of the investigation and penalties shall be communicated within 24 hours, necessarily, Ministry of Health and pharmacist sanctioned legal person who has concluded the individual employment contract and they decide, as appropriate, based on their opinion on the free practice of the profession of pharmacy, as well as on the individual employment contract.
(1) Against the penalties provided in Art. 36 para. (1) a) -c) may enter objection to jurisdiction deontological commission, within 30 days from the notification of the sanction.
(2) Against the penalties provided in Art. 36 para. (1) d) and e) may enter objection to the court within whose jurisdiction they operate pharmacist sanctioned within 30 days from the notification of the sanction.
Disciplinary responsibility of members of the College of Pharmacists in Romania, according to this law does not exclude criminal liability, civil or material law.
After a lapse of six months after the decision to suspend the authorization of free practice pharmaceutical pharmacist concerned may request reconsideration of the decision. In case of rejection, a new application can not be made until after 6 months.
Practice the profession of pharmacy by a person who has this quality constitutes a crime punishable under criminal law.
Final and Transitional Provisions
Ministry of Health is obliged to provide electoral commissions designated to organize the College of Pharmacists in Romania obvious rated pharmacists in Romania, in the Annex to this law, within 30 days of its publication in the Official Gazette.
(1) Until the election of the first county council of the College of Pharmacists in Romania and in Bucharest, enrollment in college applications are submitted to the respective election commissions, following that, within six months of that date, the Ministry of Health authorization to release free pharmaceutical practice.
(2) The first elections will be organized by electoral commissions designated the territorial pharmaceutical companies and Bucharest, on the one hand, and the county branches of pharmaceutical unions existing at the effective date of this law on the other hand, have an equal number of representatives. Election commissions are made up of six members.
(3) In the country will hold a central electoral commission, the Ministry of Health will have three representatives, pharmacists unions as a whole, three representatives and ministries with their own health network, one representative. The activity of this committee consist of validating the elections and county elections in the country; its activity ceases once the legal establishment of the first general meeting of the College of Pharmacists in Romania.
The annex is part of this law.
This law comes into force 30 days after its publication in the Official Gazette.
On the effective date of this law shall repeal any provision to the contrary.
This law was adopted by the Chamber of Deputies in the meeting of 14 April 1997, in compliance with art. 74 para. (1) of the Constitution.
P. PRESIDENT OF THE CHAMBER OF DEPUTIES IOAN ANDREI Chiliman
This law was passed by the Senate in its meeting of 18 April 1997, in compliance with art. 74 para. (1) of the Constitution.
P. President of the Senate Mircea Ionescu-Quintus
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