Amendments To The Cabinet Of Ministers Of 22 January 2013 Regulations No. 47 "pharmacovigilance Procedure"

Original Language Title: Grozījumi Ministru kabineta 2013.gada 22.janvāra noteikumos Nr.47 "Farmakovigilances kārtība"

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Cabinet of Ministers Regulations No. 10 in Riga 2014 7 January (pr. Nr. 1 24) amendments to the Cabinet of Ministers of 22 January 2013 by Regulation No 48 "pharmacovigilance" order Issued in accordance with article 5 of the law on Pharmacy-24 draw Cabinet-January 22, 2013 rules No 47 "pharmacovigilance procedures" (Latvian journal, 13, no. 22) the following amendments: 1. Express 33 and 34 point as follows: "33. State Agency of medicines on the basis of the results of the pharmacovigilance data evaluation and considerations about the potential risks of the use of the medicinal product the European Union, proposes a procedure for informing the European Medicines Agency, the European Commission, as well as the competent authorities of the EEA country where: 33.1. registration the owner is informed by the National Agency for medicines that the safety reasons it has stopped distribution of medicinal products, has acted to ensure the withdrawal of the registration of the medicinal product or intends to do so, or has not submitted the application for the registration of medicinal products; 33.2. it shall decide on the registration of the medicinal product: 33.2.1. suspension or withdrawal or refusal of renewal of the medicinal product in accordance with the regulations on the registration of the medicinal product; 33.2.2. the prohibition of the supply of medicinal products in cooperation with the health inspection in accordance with the laws and regulations on the distribution and quality control procedures.
34. the State Agency of medicines shall inform the competent authorities of the countries of the EEA, the European Medicines Agency and the European Commission, where, on the basis of considerations about the potential risks of the use of the medicinal product in the context of pharmacovigilance activities of the evaluation of the data obtained, it considers that the indication of the need for new drug contraindications, dosage reduction or focus indication. The State Agency of medicines, providing that information, offers a possible solution and the reasons for it. " 2. Supplement with 34.1, 34.2, 21.3 and 21.4 points as follows: "If 34.1 require urgent action, the State Agency of medicines shall propose to the European Union's procedure in any of the provisions referred to in paragraph 34. 21.3 If the procedures of the European Union was not started for a decentralised procedure or a mutual recognition procedure of the medicinal product in accordance with the regulations on the registration of medicinal products, the State Agency of medicines of the question shall be submitted to the coordination group. 21.3 if it is related to the interests of the European Union, the State Agency of medicines and the registration holder in accordance with the regulations on the registration of the medicinal product shall be entitled to submit the matter to the European Medicines Agency's Committee for medicinal products for human use or the pharmacovigilance risk assessment Committee. 21.4 for medicinal products which are registered in the national registration procedure, which is not a decentralised procedure or a mutual recognition procedure, the State Agency of medicines is conducting drug safety issue in accordance with these rules and regulations for the registration of the medicinal product, as well as inform the registration holder that is launched in the European Union. " 3. Replace the words "in paragraph 36 of the individual drugs or medicines group" with the words "certain medicinal products, medicinal or therapeutic range". 4. Express 37 as follows: "37. State Agency of medicines shall submit to the European Medicines Agency has available to it all the important scientific data and all medicine taken by the national agency assessments in accordance with the provisions of paragraph 33 and 34." 5. Add to the informative reference to directives of the European Union with paragraph 3 by the following: "3) of the European Parliament and of the Council of 25 October 2012 the 2012/26/EU directive, amending Directive 2001/83/EC as regards pharmacovigilance." Prime Minister Valdis Dombrovskis Health Minister Ingrida Cricket»

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