Pharmaceutical Law Amendment

Original Language Title: Grozījumi Farmācijas likumā

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/202349

The Saeima has adopted and the President promulgated the following laws: pharmaceutical law do pharmacy Act (Republic of Latvia Saeima and the Cabinet of Ministers rapporteur, 1997, nr. 10; 1998, nr. 9; 1999, no. 2; 2000, no. 2, 13, 14; 2001; 2003, no. 9., 11; 2004, nr. 10; 2006, 2. No.. No; 2007; 2008 21 no, 12, no. 24; 2009, 8. nr.) the following amendments: 1. Put article 5 (1) of the following : "1) procedures, suspension to be served, and revocable re-register special permissions (licenses) the pharmaceutical activities and veterinārfarmaceitisk activities of professional qualification certificate of pharmacist, pharmacy start-up and operational procedures, as well as medicine and veterinary medicine lieltirgotav, drugs and veterinary pharmaceutical start-up, operations, and procedures for assessment of conformity;".
2. Express article 8 by the following: ' article 8. The State Agency of medicines and health economics Centre is subordinated to the Minister of health for national regulatory authorities. "
3. Article 10: turn off paragraph 10;
make the following point 12: ' 12) evaluate medicinal products and veterinary medicinal products, medicinal products and lieltirgotav a manufacturer of veterinary medicinal products (also foreign producer) compliance with the examination of the officers of the qualifications and experience of compliance with the legislation on medicinal products and for the production and distribution of veterinary medicinal products, to the requirements and issue the special permits (licences) and veterinārfarmaceitisk pharmaceutical activities; "
to supplement the article with 14, 15 and 16 of the following: "14) carried out the conformity assessment of medical devices and the registration form and update the registry of medical devices of Latvia, shall authorise the medical device clinical studies and monitors their progress, make use of the medical devices safety oversight, create and maintain a database of observed the use of medical devices induced adverse effects;
15) take a tissue, cell and organ procurement and storage centre, treatment of blood, inter-institutional Office blood preparation Department and national blood center in conformity assessment and surveillance;
16) evaluate applications submitted to receive special permission (license) the General type of pharmacy, or the closed-end type pharmacies, with proof of space, equipment, personnel and documentation in compliance with the legislation on the operation of pharmacies and drug distribution requirements and issue the special permits (licenses) General type pharmacy or closed pharmacies. "
4. Express article 11 by the following: ' article 11. Health Economics Centre for national budget accounts payable medicine, medical equipment, medical technology and healthcare services, economic evaluation of developing guidelines for health economy, as well as provide outpatient treatments eligible for medicinal products and medical devices and hospital use of the medicinal product in the list. "
5. Replace article 64, first paragraph, second subparagraph, the introductory paragraph and the third paragraph, the words "drug price national agency" (fold) with the words "health economics Centre" (the fold).
The law shall enter into force on January 1, 2010.
The law adopted by the Parliament in 2009 on 1 December.
President Valdis Zatlers in Riga V 2009 December 21