of September 18, 2003 No. 1135
About approval of payment for issue of permissions to application of drugs, other pharmaceutical and parapharmaceutical products and for changes after registration
In pursuance of provisions of the Law on pharmaceutical activities N 1456-XII of May 25, 1993. (The monitor of Parliament of the Republic of Moldova, 1993, N 7, of the Art. 210) and for the purpose of further development of process of quality assurance of the drugs permitted in the pharmaceutical market, the Government DECIDES:
1. Approve according to the appendix N1 the amount of payment for permission to application of drugs, other pharmaceutical and parapharmaceutical products and for changes after registration.
2. Approve the list of the paid services rendered by National institute of pharmacy according to the appendix N2.
3. Permissions to use of medicines, other pharmaceutical and parapharmaceutical products, and also the changes made after registration are performed by National institute of pharmacy.
4. The amounts received from issue of permissions to application of drugs, other pharmaceutical and parapharmaceutical products and also for changes after registration, are transferred into the special account of National institute of pharmacy.
5. The means transferred into the special account are used for support and development of process of registration and issue of permissions, and also the organizations of experimental production of drugs, developments and deployments of information systems, equipment of the relevant organization by the equipment, the equipment and raw materials, construction and capital repairs, the organization and participation in national and international forums concerning medicine and pharmacy are distributed for the purpose of financing of research programs in the field of medicines and pharmaceutical activities, expert works.
6. Bring in the Order of the Government N 596 of July 1, 1997. "About state registration and certification of medicines and products of medical appointment" (The official monitor of the Republic of Moldova, 1997, N 49-50, Art. 531) the following changes:
in Item 1 to exclude words of "medicinal and diagnostic medicines, immunobiological, radio pharmaceutical, narcotic, cosmetic, supportive and other applications";
in Item 2 to exclude words "medicinal and diagnostic medicines, immunobiological, radio pharmaceutical, narcotic, cosmetic, supportive and other applications, and also".
Prime Minister
Vasile Tarlev
|
Minister of Economic Affairs |
Marian Lupu |
|
Minister of Finance |
Zinaida Grechany |
|
Minister of Health |
Andrejs Hermann |
Appendix
to the Order of the Government No. 1135 of September 18, 2003
+-----------------------------------------------------------------+ ¦ N ¦ ¦ Леев за одну ¦ ¦п/п ¦ ¦лекарственную форму ¦ ¦ ¦ ¦ или дозу ¦ +----+---------------------------------------+--------------------¦ ¦I. ¦Разрешение на применение лекарственных ¦ ¦ ¦ ¦ средств ¦ ¦ +----+---------------------------------------+--------------------¦ ¦1. ¦Аллопатические лекарства, в том числе ¦ ¦ ¦ ¦стоматологические изделия, ¦ ¦ ¦ ¦наркотические вещества, ¦ ¦ ¦ ¦радиофармацевтические средства, ¦ ¦ ¦ ¦витамины, препараты из крови: ¦ ¦ ¦ ¦ ¦ ¦ ¦ ¦а) включенные в группу основных и ¦9000 ¦ ¦ ¦жизненно важных под общим названием ¦ ¦ ¦ ¦Ь) лекарства под коммерческим ¦13500 ¦ ¦ ¦(фирменным) ¦ ¦ ¦ ¦названием ¦ ¦ ¦ ¦ ¦ ¦ ¦2. ¦Дополнительная доза того же препарата ¦4500 ¦ ¦ ¦ ¦ ¦ ¦3. ¦Гомеопатические, фитотерапевтические ¦4500 ¦ ¦ ¦препараты, в том числе типа чая, ¦ ¦ ¦ ¦парафармацевтическая продукция, ¦ ¦ ¦ ¦биологические и чисто косметические ¦ ¦ ¦ ¦препараты, средства личной гигиены ¦ ¦ ¦ ¦ ¦ ¦ ¦4. ¦Лекарственные вещества,
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The document ceased to be valid since May 30, 2014 according to the Order of the Government of the Republic of Moldova of May 26, 2014 No. 348