Cabinet of Ministers Regulations No. 461 in Riga august 19, 2003 (pr. No 45, § 4) amendments to the Cabinet of Ministers on 31 October 2000 by Regulation No 381 "rules of registration of medicinal products" Issued in accordance with article 5 of the law of Pharmacy (3) to make a Cabinet of 31 October 2000 of Regulation No 381 "rules of registration of medicinal products" (Latvian journal, 2000, 391./393.nr.) the following amendments: 1. Replace the text of the provisions: 1.1., the words "the Minister of welfare" (fold) with the words "Minister of health" (fold);
1.2. the words "Ministry of welfare" (fold) with the words "Ministry of health" (fold).
2. Supplement with 6.1 points by the following: "6.1 the national medicines agency is entitled health reasons in exceptional cases accept the decision (after consulting the Health Minister) for the evaluation of medicinal products, registration, re-registration and other registration-related activities to the exemption from fees or fee reductions, if the product is essential to the process of treatment, for treatment of a rare disease or distributed in limited quantity."
3. Supplement with 19.4. subparagraph by the following: "19.4. medications are not significantly different from that of a medicinal product for at least six years are registered (allowed for distribution) in a Member State of the European Union and the European economic area and is recorded and distributed in Latvia. 20. These provisions referred to in paragraph 1, products obtained by using the advanced technology techniques, this period is not less than 10 years. The State Agency of medicines has the right not to apply this six-year period, if the product is expired patent term. If the medicinal product is intended for a different therapeutic indications, they have a different route of administration or dosage, the applicant shall provide appropriate pharmacological and toxicological tests or clinical trials. "
4. Replace paragraph 54, the word "application" with the word "submission".
5. To replace the words "in subparagraph 141.1. technical regulations" with the words "technical regulations".
6. To express the following subparagraph 141.4.: "141.4. information contained in the registration dossier is incorrect or not updated in accordance with this rule 15.2. the conditions referred to in (a) or has not been carried out and their ingredients (medicinal products and their components also control the production process at an intermediate state of the medicinal product, in accordance with the provisions of paragraph 11.6 methods laid down in);".
7. Supplement with 141.7 141.6.,.,., and 141.9 141.8. subparagraph by the following: "141.6. judgment of the Court is on the infringement of intellectual property rights, taking into account the distribution to which the judgment of the Court of Justice applies;
the applicant for registration is 141.7. submitted a request to cancel or suspend the registration of the medicinal product;
141.8. registration dossiers comply with European Community law;
These provisions have been taken to 141.9. the payments referred to in paragraph 6. "
8. Make 147. paragraph by the following: "147. national medicines agency decision may be challenged by the laws governing administrative proceedings, in accordance with the procedure laid down, by the application of the Ministry of health. The Ministry of health decision may appeal to the Court. "
9. Make 152 the following wording: "152. Registration certificate holder (owner) or an applicant for registration must be registered in the European Community."
10. in paragraph 157 deleted, and the words "until 2002 December 31."
11.158.161. Be removed, and 162 points.
12. Supplement with 165, 166 and 167.. the following points: the "165. This rule 19.4. and 141.8.152 and shall enter into force with special cabinet rules.
166. the Cabinet of Ministers regulations specific for the entry into force of the registration certificate holder (owner), registrations to the applicant or his authorized representative must be in the legal (registered firm, Central Administration or place of business) or the candidate countries of the European Community.
167. This rule 19.3 above, paragraph 157 and annex, 10.1, 10.2, 12.1, 18.1 and 18.2 point shall cease to apply to specific Cabinet rules. "
13. To supplement the rules with the informative reference to European Union directives as follows: "Informative reference to European Union Directive provisions included in the law arising from Directive 2001/83/EC."
14. the supplement attachment with 10.1 and 10.2 point as follows: "10.1 E 128 Red 2 g red 2 g E 129 Allur Red EYE 10.2 allura red AC".
15. the supplement attachment with 12.1 points by the following: "E 133 brilliant blue 12.1 FCF FCF Brilliant".
16. To supplement the annex to 18.1 and 18.2 points for the following: "E 154 Brown FK 18.1 Brown FK E 155 Brown HT 18.2 Brown HT".
Prime Minister e. Repše Health Minister i. Cricket is the Editorial Note: the entry into force of the provisions to 23 august 2003.