Amendments To The Cabinet Of Ministers May 9 2006, Regulations No. 376 "the Procedure Of Registration Of Medicinal Products"

Original Language Title: Grozījumi Ministru kabineta 2006.gada 9.maija noteikumos Nr.376 "Zāļu reģistrēšanas kārtība"

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Cabinet of Ministers Regulations No. 563 in Riga in 2007 (august 21. No 46 16) amendments to the Cabinet of Ministers may 9 2006, regulations No. 376 "registration procedure for medicinal products" Issued in accordance with article 5 of the law of Pharmacy (3) to make the Cabinet may 9 2006, regulations No. 376 "registration procedure for medicinal products" (Latvian journal, 2006, 97. nr.) the following amendments: 1. Make paragraph 6 by the following: "6. the State Agency of medicines has the right to decide on the conformity of pharmaceutical products in the statutory definition of a drug. The State Agency of medicines shall jointly with the appropriate competent authorities and independent experts organized by product. Assessing all the characteristics of the product, in particular take into account: 6.1. qualitative and quantitative composition;
6.2. the pharmacological properties of the product and its compliance with the level of development of science;
6.3. product usage and form, as well as the fact, or similar product is registered as a drug;
6.4. product distribution;
6.5. the visibility of the product to consumers;
6.6. the risks that may result from use of the product;
4.2. product presentation (marking, instructions, advertised and all kinds of product information). "
2. Supplement with 17.22. bottom point as follows: "If 17.22. the product contains active substances derived from specimens referred to the 1973 Washington Convention on international trade in endangered species of wild fauna and flora in the annexes and the Council on 9 December 1996, Regulation (EC) No 338/97 on the protection of species of wild fauna and flora by regulating trade therein, attachments, requesting receipt-registration that the extraction of specimens in the country of origin is effected pursuant to the said requirements laid down in the Convention."
3. Delete 120.4.5.. Prime Minister a. Halloween Health Minister v. Veldr MC