Key Benefits:
See the copyright notice Conditions of use .
In accordance with the decision of the Parliament:
The Agency is a central agency of the Ministry of Social Affairs and Health, which promotes the health and safety of the population through the control of medicines, blood and tissue products and the development of the pharmaceutical sector.
The Centre shall be responsible for:
(1) provide for the advance and ex post control of medicinal products, guide and control the manufacture, import, distribution, marketing and consumption of medicinal products and provide scientific advice;
(2) act as a regulatory authority for the non-clinical safety studies of medicinal products and chemicals and clinical trials;
(3) establish the relevant pharmacopoeia and participate in standardisation work in the pharmaceutical sector;
(4) ensure the quality and safety of human blood and parts thereof, as well as the control of blood establishments;
(5) ensure the quality, safety and control of human organs, tissues and cells intended for human use, and tissue establishments;
(6) take care of the control, authorisation, control and information management tasks set out in the legislation on drugs;
(7) to carry out a pharmaceutical-epidemiological, pharmaceutical and pharmaceutical research and to develop cooperation in these research areas;
(8) produce and compile the therapeutic and economic value assessments of medicinal products and coordinate cooperation in this field;
(9) to build cooperation between the therapeutic and economic evaluation of vaccines;
(10) to collect, evaluate and transmit information on medicinal products to the population, to those in the social and health care sector and to those in need of information;
(11) develop the functioning and safety of the pharmaceutical and pharmaceutical sector, including the pharmaceutical industry;
(12) to provide for general provisions on the provision of medicinal products and the law on the storage of medicinal products; (979/2008) The tasks assigned to it;
(13) maintain statistics relating to its field of activity;
14) to participate in and influence the activities of the European Union and other international activities.
In addition, the Centre shall carry out specific or specific tasks assigned to it, as well as the tasks assigned to it by the Ministry of Social Affairs and Health.
The Centre shall carry out its tasks in cooperation with the authorities, universities and research institutes, social and health services and other actors in the sector.
The Centre is led by the Supreme Leader. The Director-General shall decide on the matters to be decided by the Centre which are not provided for by the Rules of Procedure or by the Rules of Procedure, which shall be settled by the panel, the committee or any other official in the service of the Centre. The Director General shall adopt the Rules of Procedure.
The Centre shall be set up for a period of three years by the Supervisory Board and the Pharmacopoeia Committee which the Centre shall set. In addition, the Centre may set up other panels and delegations.
The Board of Supervisors shall be composed of the President and the Vice-Chair, who shall be officials of the Centre and three other members. One should represent pharmaceutical and one legal expertise and one to be an expert in the social and health field. The members of the panel shall have a personal alternate.
The supervisory board shall address and settle matters relating to:
1) Pharmaceutical (395/1987) § 8 And the withdrawal of the authorisations referred to in Article 32 of that Law, as referred to in Article 32 of that Law, and the withdrawal of the authorisations referred to in Article 101a of that Law;
(2) blood establishments (197/2005) § 4 And the withdrawal of the authorisation referred to in Article 21 of that Law;
(3) the law on the medical use of human organs, tissues and cells (101/2001) Article 20b And the withdrawal of the authorisation referred to in Article 20m of that Law;
(4) the granting of a pharmacy licence as referred to in Articles 40 and 43 of the Pharmaceutical Act, the temporary prohibition referred to in Article 49 of that Law is to be carried out by the pharmacy and the withdrawal of a pharmacist within the meaning of Article 50 of that Law;
5) Disciplinary measures referred to in Article 51 of the Pharmaceutical Code.
The role of the Farmakopf Committee is to make proposals and deliver opinions on the pharmacopoeia.
The composition of the Farmakopeic Committee and other organisation of the activities of the Board of Directors and of the Supervisory Board are laid down in greater detail by a decree of the Government.
The Centre may conclude contracts for the carrying out of tasks and studies relating to the implementation of research projects and programmes, as well as for carrying out investigations and carrying out work. The Centre may, within its budget, use external experts.
Without prejudice to the provisions on professional secrecy, the Centre may disclose information necessary for the performance of its tasks within the meaning of paragraph 1. The person acting as an expert in the Centre shall be subject to the provisions relating to criminal liability. The Centre's experts are set out in more detail by a decree of the Government.
The Centre shall, for the purposes of monitoring the quality of medicinal products and equipment and articles relating to their use, and for the purposes of the pharmacopoeia, the right to take samples of samples from the manufacturer, importer, brokerage, wholesaler, seller or other type of consumption. The donor.
The Centre shall have the right to receive, free of charge and without prejudice to the confidentiality rules, the following information where they are necessary for the performance of the tasks set out in Article 2:
(1) information on the reimbursement and wholesale price of the medicinal product at the price committee of the medicinal products;
2) Statistics and records on the prescription and reimbursement of medicinal products from the Social Insurance Institution;
3) Statistics and records of the health and welfare institution;
4) Data from the Agency for Social and Health Authorisation and Control.
The Centre shall not disclose information obtained in the course of carrying out tasks under this law from a private or Community trade or professional secret or other confidential information.
The decree of the Council of State provides for the establishment of the Centre's senior officials, qualification requirements and employment.
The Centre's Rules of Procedure:
(1) its organisation;
(2) the exercise of the authority;
(3) internal management;
4) other matters within the internal administration of the Centre.
The organisation of the centre shall be organised in such a way that the authorisation procedure, control and control are functionally separate from the research tasks.
This Act shall enter into force on 1 November 2009. This law repeals the Law on Medical Products (35/1993) And the Law on the Development of Medicinal Products (1080/2002) With their subsequent modifications.
At the time of entry into force of this Act, pending cases in the Centre for the Development of Medicinal Products, the associated agreements and commitments, and the resulting rights and obligations under this Act or any other law of the pharmaceutical sector To the Centre for Security and Development, to be transferred to the Centre for Safety and Development in the pharmaceutical sector. Law on health care equipment and supplies (1505/1994) And the associated agreements and commitments, as well as the rights and obligations arising therefrom, shall be transferred to the Social and Health Authorisation and Control Agency. The matters and the related rights and obligations arising therefrom and the rights and obligations arising therefrom and the rights and obligations arising therefrom shall be transferred to the health and welfare institution and shall be addressed. Matters relating to the specific control of vaccines and related agreements and commitments, as well as the rights and obligations arising therefrom, shall be transferred from the Health and Welfare Institute to the Agency for Safety and Development in the pharmaceutical sector.
At the time of entry into force of this Act, the provisions adopted by the Institute shall remain in force until further provision or provision is made.
From 1 November 2009, the post of Director-General of the Civil Service Tribunal shall be established on 1 November 2009. (18/04/1994) Provisions. The sentence may be filled before the entry into force of this Act. When the law comes into force, the post of Director General of the Medicines Agency will cease. The termination of the office shall not require the consent of the official. In the event of a failure, the resulting error ratio will cease without notice.
The staff of the Centre for the Evaluation of Medicinal Products and the Centre for the Development of Medicinal Products, as well as the staff of the Centre for the Development of Medicinal Products, and the corresponding posts will be transferred upon entry into force of this Act to the Pharmaceutical Safety and Development Centre. The staff of the Institute for Social and Health Authorisation and Control, as well as the corresponding posts, will be transferred from the date of entry into force of this Act to the Social and Health Authorisation and Control Agency. The staff of the Centre for Health and Welfare and the staff of the Centre for the Development of Medicinal Products, as well as the corresponding posts, will pass from the entry into force of this Act to the health and welfare establishment. However, the Director-General of the Institute and his office will not be transferred. In the health and welfare establishment, the official responsible for the tasks of the Agency for the safety and development of the pharmaceutical sector at the time of entry into force of this Act shall pass through the entry into force of this Act to the Agency for Safety and Development in the pharmaceutical sector. The temporary staff shall be transferred for the duration of the secondment.
No official's consent shall be required for the transfer of posts, unless the post is transferred from one employment area to another. Transferring staff shall retain the rights and obligations attached to the service at the time of the transitional period and their remuneration in euro. If the functions of the post are substantially altered and a new post is created in its place, a new post can be filled in without a claim.
The measures necessary for the implementation of this law can already be taken before the law enters into force.
THEY 74/2009 , StVM 21/2009, EV 96/2009
