Cabinet of Ministers Regulations No. 1106 in Riga 2009 September 29 (pr. No 63 12) 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 importation and distribution of medicinal products order (Latvian journal, 2007, 104 no; 2008, 92 no) the following amendments : 1. Replace the text, the words "sanitary border inspection" (fold) with the words "food and veterinary service" (fold).
2. Delete paragraph 4, the words "sanitary border inspection (hereinafter referred to as the sanitary border inspection)".
3. To make point 7 by the following: "7. the customs warehouse in which to store the medicines required health inspections on compliance with the laws and regulations of the warehouse for distribution to those of medicine storage requirements."
4. Supplement with 35.1 35.2 35.3 35.4 points, and such that: "the State Agency of medicines of 21.8 on the basis of the medicinal products or active substances (products) in Latvia registered the application or by the manufacturer of the third-country competent authority shall issue a certificate of the product, the short format-pharmaceutical product certificate or free trade certificate (hereinafter referred to as the short certificate). A short certificate is issued to one type of product (in Latvian and in English). Unless the medicinal product have different strength, they should be considered as one type of product. Unless the medicinal product have different dosage forms (such as tablets, solution), each pharmaceutical form submitted for the application and issue a separate short certificate.
the certificate presented in Abbreviated 35.2, taking into account the submission contains the requirements of the third country, in so far as they do not conflict with the World Health Organization (who) guidelines for pharmaceutical products quality certification scheme for the international trade. Short certificate shall specify at least the following information: 1. the certificate name 35.2: "pharmaceutical product certificate" or "certificate of free trade" according to the requirements of a third country;
21.9 2. product name. Specifies the strength of the medicinal product (active substance (s), the quantity per dosage unit volume or mass) and the pharmaceutical form. Active substance indicate the international non-proprietary name (INN) or, failing that, the chemical name. In Latvia the medicinal indicates a registration number, the registration date and expiration date, if applicable;
35.2 3. product composition. The active substance of dosage dosage a single point in the unit (the unit);
21.9 4. manufacturer's name (merchant), the unified registration number in the trade register, legal address, special permission (license) (if any) name, number, issuer, issue date, expiration date, and shop floor address;
35.2 5. for placing the medicinal product on the market, the person responsible for the name or firm and business address (applies to Latvia registered medicinal products);
35.2 6. name of the person or firm and business address of that name supposed to register medicines (applies to medicinal products submitted for registration in Latvia or in another country);
35.2 7. If the product is in the process of registration, it shall be indicated. If the product is not intended for registration, indicate "not intended for placing on the market of Latvia register" or "for export only". If the medicinal product or an active substance is not permitted to distribute in Latvia, indicates the appropriate reasons, such as "stop", "registration registration registration cancelled" or "rejected". Active substance indicate "not registered" or "export only";
35.2 8. certification that the product concerned can be freely marketed third country market in accordance with national legislation and the requirements laid down on the basis of a particular manufacturer (specify name), quality specifications and that the quality of the product is responsible for a particular manufacturer, which is subjected to regular good manufacturing practice inspection and certification procedure (indicates the frequency of carrying out checks in accordance with the laws and regulations on drug production and control procedures).
35.3 short certificate indicates that the corresponding product quality specification is based on the quality of the European Pharmacopoeia and the manufacturer of the active substance quality specifications, if abbreviated application requesting the certificate is specified the following information need, giving it with a third country. Such information is not required if the product is the European Directorate for the quality of medicines issued a certificate of conformity.
Accelerated certificate added 35.4 Summary of product characteristics, package leaflet and labelling. This requirement does not apply to short form certificate, which is issued to active substance. "
5. Supplement with 37.1 points as follows: "to get this rule 23.1 21.8 short certificate referred to in paragraph 1, the manufacturer of the medicinal product registered in Latvia shall provide the State Agency of medicines of the submission. The application shall specify: 1. the certificate applicant 37.1, the name or business name and address;
37.1 2. a third country, the competent authority and the requirements for the certificate to be short information, as well as third country requirements for good manufacturing practice certificate, if applicable;
37.1 3. this rule 35.2 35.2.1, 2, 3, 4.35.2 35.2, 35.2, 35.2 5.6 and 21.8 7. information referred to in point. If the product is submitted for registration, indicate the State (s) in which the registration application. If the product is not registered in Latvia, the State (s) where the product is registered;
37.1 if the short certificate 4 this provision to be included in the information referred to in paragraph 35.3, the application shall be accompanied by the quality of the product specification. Medicinal products shall also be submitted to the active substance (s) the manufacturer's quality specification (s). "
6. Supplement with 38.1 points as follows: "the State Agency of medicines of 38.1 this provision in paragraph 21.8 short certificate is issued within 30 days after receipt of the application. If the product has been granted a 21.8. these provisions referred to in the certificate of the product and does not require repeated good manufacturing practice compliance assessment or these rules referred to in paragraph 35.3 evaluation, the rules referred to in paragraph 21.8 short certificate issued by the State Agency of medicines shall within 10 days after receipt of the application. Expenses associated with the short certificate, according to the State Agency of medicines of the public paid the price list shall be borne by the applicant. "
7. Supplement with 24.3 points of chapter IV as follows: "If this rule 39.1 21.8 abbreviated referred the issue of the certificate, require the production of the product space and good manufacturing practice certificate of conformity assessment, the applicant asked the State Agency of medicines to assess the product's conformity with good manufacturing practice and to issue the certificate of good manufacturing practice. The State Agency of medicines that the verification and certificate of good manufacturing practice shall be issued in accordance with the laws and regulations on the production and control of medicinal products. "
8. Replace the introductory paragraph of point 41, the word "may" with the word "eligible".
9. Replace the introductory paragraph of paragraph 44, first sentence, the word "adopted" with the word "adopted".
10. Deletion of informative references to the directives of the European Union in paragraph 4, the words ' as regards traditional herbal medicinal products. "
Prime Minister Dombrovskis v. Minister of health b. Rosenthal is the Editorial Note: rules shall enter into force on the 3 October 2009.