Amendments To The Cabinet Of Ministers Of 26 June 2007 Regulation No 436 Of "import And Export Of Medicinal Products Order

Original Language Title: Grozījumi Ministru kabineta 2007.gada 26.jūnija noteikumos Nr.436 "Zāļu ievešanas un izvešanas kārtība"

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Cabinet of Ministers Regulations No. 415 in Riga in 2008 (10 June. No 38 25) amendments to the Cabinet of Ministers of 26 June 2007 No. 436 "provisions of the import and export of medicinal products order Issued in accordance with article 5 of the law of Pharmacy (3) and the law" on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order "article 28 do cabinet 26 June 2007 No. 436" provisions of the import and export of medicinal products order (Latvian journal, 2007, 104 no) the following amendments: 1. Replace the text, the words "the State Pharmaceutical inspection" (fold) with the words "health inspection" (fold).
2. Express 2.4. subparagraph by the following: ' 2.4. sample of the medicinal product, including the substance used as reference substances testing of medicinal products (hereinafter referred to as the reference sample) import; ".
3. Express the point 20 as follows: "20. Before conclusion of the contract on the quality control of medicinal products, the importer shall ensure that the State Agency of medicines shall deliver an opinion on the compliance of laboratories of good manufacturing practice requirements of the European Commission's guidelines on medicinal products and investigational medicinal products good manufacturing practices."
4. Make the following paragraph 39:39 ". If this rule 35.1. referred to in the certificate is issued for a product that is an active substance for use in the form of medicinal products, active substances required place assay and active substance of good manufacturing practice certificate of conformity assessment, the applicant asked the State Agency of medicines to take active substance production conformity assessment. This test is carried out and a certificate of good manufacturing practice for medicinal products issued by the national agency, in accordance with the laws and regulations on the production and control of medicinal products. "
5. Replace annex 1, the words "for use in" test laboratory "for use in the testing of medicinal products". Prime Minister i. Godmanis Health Minister Morris I.

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