Updated 27.05.2010, Latvian Journal No. 83 (4275) Cabinet of Ministers Regulations No. 453 in Riga, 18 May 2010 (pr. No 25 19) amendments to the Cabinet of Ministers may 9 2006, regulations No. 376 "registration procedure for medicinal products" Issued in accordance with article 5 of the law of Pharmacy (3) to make the Cabinet may 9 2006, regulations No. 376 "registration procedure for medicinal products" (Latvian journal, 2006, 97 no; 2007; 2008, nr. 137.117. no; 2009, 178. no) the following amendments: 1. Replace the text, the words "home page" on the internet (the fold) with the words "Web site (http://www.zva.gov.lv) ' (the fold).
2. Make a point 5 and 6 by the following: "5. If the product, taking into account all the characteristics of the product, in accordance with the provisions of paragraph 6 of the medicinal products referred to in the opinion of the public agency meets the definition of a medicinal product, it is subject to registration in accordance with the procedure laid down in these provisions.
6. the State Agency of medicines has the right to give an opinion on a product (for example, food, medical devices, cosmetics, biocides) compliance with pharmaceutical statutory definition of medicinal products, if the application is received, or by the State Agency of medicines or other competent national authority. "
3. Replace paragraph 10, second sentence, the words "the validity of the registration" with the word "renewal".
4. Make the following paragraph 11: "11." After this provision referred to in paragraph 8 of the decision with respect to any changes in the registration and enrollment expansion of State Agency of medicines shall adopt one of the following decisions: 11.1. this rule 68.1. a decision as referred to in point registration (registration expansion case);
11.2. this rule 68.2. the decision referred to in the subparagraph on the transmit of authorisations requested changes (including new marketing packages, route of Administration). This decision is an integral part of these rules in the decision referred to in paragraph 8;
11.3. the decision on refusal of registration of the medicinal product;
11.4. the decision on the approval of the change. "
5. Supplement with 11.1, 11.2, 11.3 and 11.4 points as follows: 11.1 9. These provisions ", 10 and 11 the decision referred to in paragraph shall enter into force by the time of its adoption.
11.2 If, assuming any of this rules 11.1 or 11.2. the decisions referred to, changing the registration certificate contains data (such as the name of the medicinal product, the owner of the registration, the information on the packaging), the State Agency of medicines within three working days after the decision provides new medicines the issue of registration certificate (annex 1).
11.3 grass considered registered in Latvia, where this provision in paragraph 9, 10, 11.1, and in paragraph 14 of that decision is in force.
11.4 these terms does not apply paragraph 11 concerning herbal medicines, which are recorded in this provision set out in Chapter VII of the simple registration procedure it. "
6. To express the following paragraph 12: ' 12. Adopting these rules 11.1 and 11.2 in that decision, the State Agency of medicines shall take into account all the conditions, including the rules referred to in chapter III of the conditions under which this provision was adopted, paragraph 9 of decision. "
7. Supplement to chapter I, 15.1 and 15.2 paragraph by the following: "15.1 the State Agency of medicines at the same time with these regulations 9, 10, 11 and 14 of the decision referred to in paragraph into force ensures the State Agency's Web site (http://www.zva.gov.lv) (hereinafter referred to as the Web site (http://www.zva.gov.lv)) public availability of the following Latvian medicine registry data: 15.1 1. name of the medicinal product, pharmaceutical form, strength or concentration, the packing unit number;
15.1 2. the active component (s) international non-proprietary name (INN);
15.1 3. registration the owner's first name, last name or company name, but a parallel imported medicinal product imported in parallel authorization − the distribution of medicinal products in the Republic of Latvia, the holder and the name of the country;
15.1 4. manufacturer's name, including the State;
15.1 5. anatomic therapeutic chemical (ATC) classification code;
15.1 6. date and number of the registration. Parallel imported medicinal products – permits parallel distribution of medicinal products imported in the Republic of Latvia;
15.1 7. the approved summary of product characteristics, package leaflet and labelling methods;
15.1 8. medicine classification group designation, granted in accordance with the regulations on the classification of the medicinal product.
15.2 National Agency for medicinal products medicinal products shall be deleted from the register of medicinal products of Latvia, if: 15.2 1. entry into force of this regulation, paragraph 114 of the decision on the cancellation of the registration;
15.2 2. in accordance with the provisions of paragraph 125. decision on registration has lapsed. "
8. Express 18 as follows: "6. the registration of the medicinal products specified in the documentation contained in the colouring matter in foodstuffs comply with the authorized colouring matters, and they apply the same specific purity criteria and analysis of compliance with these criteria shall apply to the foodstuffs of colouring matters authorised in accordance with the laws and regulations on minimum safety requirements for food additives. Products produced for export can be added to the other colours if colours are allowed a country to which export of medicines. "
9. Add to paragraph 20 with the third sentence by the following: "any use of scientific literature experts justify this provision. According to paragraph 28.2 and according to this provision, 4. the conditions laid down in the annex."
10. Replace 40.4 in words and numbers "Commission of 3 June, Regulation (EC) No 1085/2003 concerning the examination of variations of a marketing authorisation for medicinal products for human use and veterinary medicinal products conditions, within the scope of Council Regulation (EEC) No 2309/93 (hereinafter referred to as Commission Regulation No 1085/2003)" with the words and figures "European Commission 24 November 2008 by Regulation (EC) No 1234/2008 concerning the examination of variations of a marketing authorisation for medicinal products for human use and veterinary medicinal products for conditions (hereinafter referred to as Commission Regulation No 1234/2008)".
11. Replace 46.2. in words and numbers "in Commission Regulation No 1085/2003" with the words and figures "in Commission Regulation No 1234/2008".
12. Replace paragraph 53, the number "48" with the number "50".
13. Replace 65.2 in words and numbers "of the European Commission of 3 June 2003, Regulation (EC) no 1084/2003 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State relating to medicinal products for human use and veterinary medicinal products (hereinafter referred to as Commission Regulation (EC) no 1084/2003)" with the words and figures "Commission Regulation No 1234/2008".
14. Replace 65.3 in words and numbers "Commission Regulation No 1085/2003" with the words and figures "Commission Regulation No 1234/2008".
15. Supplement with 65.1 points as follows: "this provision 65.1 65 shall not apply to the homeopathic (also antropozofaj) and traditional herbal medicinal products established in the simplified registration procedure."
16. Replace paragraph 66, the words and figures "in Commission Regulation No 1084/2003" with the words and figures "in Commission Regulation No 1234/2008".
17. the express section 84.1. by the following: "84.1. regarding the quality, safety and effectiveness, where the registration dossier is submitted that rule 9 or 10 or in paragraph 11.1. referred to in the decision and which includes all the changes introduced following the adoption of that decision (consolidated version of the registration dossier);".
18. Express 84.2.1 and subparagraph 84.2.2. this.: "84.2.1. evidence and clinical expert's claim that the risk-benefit balance remains favourable. Clinical expert's assertion is based on data collected since the registration or re-registration;
84.2.2. periodically report of security according to the law vajiem in normat for pharmacovigilance procedures and, if applicable, a summary of all of registration submitted periodically renewed security messages. "
19. the supplement to chapter XI 84.1 and 52.3 points as follows: "this rule 84.1 in paragraph 84 of the applications submitted for registration to the national agency of medicines for at least six months before 9 or 10 of these regulations or paragraph 11.1. the decision referred to in paragraph expires.
If the product is registered 52.3 national registration procedures and the application is filed before this rule 84.1 in referred to the application deadline, the registration holder shall be entitled to agree with the State Agency of medicines of the renewal date. "
20. Express 85 as follows: "85. Medicines, registration, renewal, change approval and post-marketing surveillance (hereinafter service) costs (with the annual registration costs) shall be borne by the person in whose name the registration Hall is planned (but in relation to the product documentation for the assessment of compliance with the definition of a medicinal product-the applicant), pursuant to Cabinet of Ministers of 17 January 2006, the Regulation No 61" rules for the State Agency of medicines of the public paid services price list "(hereinafter referred to as the State Agency of medicines of the public paid price)."

21. Supplement with 85.1, 85.5 85.2 85.3, 85.4,,, and 53.3 points 85.6 as follows: "before the launch of 85.1 recipient of the full amount paid in advance by the National Agency for medicines public service charge list of annex 1., 2., 3., 4., 5., 6., 7., 8., 9, 10, 11 and 13 of the services referred to in points. For services paid through non-cash settlement.
85.2 submitting services the necessary documents, the applicant adds credit certified payment orders or with credit institutions Internet banking payments made through print, stating that rule referred to in paragraph 85.1 prepaid, if the output contains a clearly legible name of the payer name and signed by the person or, if cash settlement is made with a payment card, the State Agency of medicines receipt Cashless settlement.
service performance: 85.3 85.3 1. launched by this provision the payment referred to in paragraph 85.2 production of supporting documents and the appropriate amount of money the State Agency of medicines of the transfer to the operating account;
2. you can stop with 85.3 medicine State agency decision pharmaceutical law in article 31 and of the rules and the 88.114. in the case referred to in paragraph and in order, as well as on the basis of the recipient's application for a waiver of service.
85.4 interrupting service performance, the State Agency of medicines of the rules received 85.1 points in prepaid shall bear the costs for the work carried out up to the termination of the services concerned, in the following order: 1. If you have 85.4 this rule 86.1. referred to registration and re-registration of the application, the primary inspection, to 10 percent of the fee;
2. If you have 85.4 this provision referred to in paragraph 1 85.4 primary expertise and have launched the application data and documents attached to the evaluation (inspection of the documentation) of the Cabinet of Ministers of 17 January 2006 no. 61 of the provisions of the "regulations on the State Agency of medicines of the public paid services price list" 1., 2., 3., 4., 5., 6., 7., 8, 9, 10 and 11 set out in point services, and 50 percent of the fee;
3. If you have 85.4 application data and documents attached to the evaluation (inspection of the documentation), the National Agency for medicines public service charge list of annex 1., 2., 3., 4., 5., 6., 7., 8, 9, 10 and 11 above services, 90 percent of the cost.
85.5 85.4 these rules in the cases referred to the State Agency of medicines on the basis of the recipient's application for money back, prepare them and the amount of money released through wire transfer with credit mediation within 30 calendar days of the recipient's receipt of the application for a refund of the State Agency of medicines. The recipient of the service, the application for repayment shall be entitled to submit these rules 85.3 2. in the cases referred to. Application for repayment by the recipient of the service specifies the properties of a credit institution and account number to State Agency of medicines should be carried out money transfers.
post-marketing surveillance of medicines 85.6 annual fee shall apply in the next calendar year by this provision in paragraph 9 or 10 or decision taken in paragraph 11.1.
85.7 based on registration of the owner of the application, the State Agency of medicines has the right to take the decision to release from the post-marketing surveillance of medicines a year fee, if the following conditions are met: 1. the marketing of the medicinal product 53.3 price is declared in the State Agency of medicines in accordance with the laws and regulations on drug pricing principles;
2. medicinal products in Latvia, 85.7 are prevalent, but drug turnover in the previous calendar year has not exceeded 1500 lats;
3. the registration owner 53.3 has reported the State Agency of medicines of the actual distribution of medicines (trade) launch date in Latvia or for medicinal products which are placed on the market in Latvia last (temporarily or permanently) in accordance with the regulations on the procedure of distribution of medicinal products. "
22. Make 86.1. the introductory part of point as follows: "the primary inspection carried 53.5. the registration and re-registration of the application, compliance with the requirements of this Regulation (the primary inspection is not carried out, confirming the changes):".
23. To supplement the rules by 86.1.3. section as follows: "86.1.3. within 10 days after receipt of the application for the renewal of the national agency of medicinal products;".
24. Make the following subparagraphs 86.2.: "86.2. checks are appropriate to the circumstances of the decision on registration, and until a decision shall take all necessary action to ensure the discharge of the procedure. Decision of the administrative procedure law, providing data and document evaluation for 210 days of the submission of the application for registration of the State Agency of medicines (medicines registered only national registration procedure, but not recorded in the mutual recognition procedure or the decentralised procedure). If the decision is taken in respect of national registration procedure for generic medicinal product to be registered, the registration shall be adopted by the administrative process law, not exceeding 90 days. The State Agency of medicines is not the competence of the patent rights related to the verification of the information. "
25. the express section 89.3. by the following: "89.3. in accordance with the development of the registration dossier assessment report and comments on the pharmaceutical and clinical tests and clinical trials. This does not apply to the homeopathic, antropozofaj and herbal medicinal products established in the simplified registration procedure. The assessment report shall be updated when new information becomes known, which is important for the quality of the medicinal product concerned, safety or effectiveness evaluation; ".
26. Delete 89.4.1..
27. Express the following introductory paragraph 90:90. "State Agency of medicines has the right, in exceptional cases, after consultation with the principal applicant for the registration of objective and verifiable reasons to take a decision on the registration of the applicant to comply with the conditions laid down, in particular as regards the safety of the medicinal product, notification to the competent authority of any incident related to the use of the medicinal product and of the activities which are enforceable in this respect, if one of the following circumstances :".
28. Add to subparagraph 91.2. in the second sentence by the following: "performance results will be taken into account in this provision, respectively, 93, 94 10. or decision referred to in paragraph 114;".
29. Replace 93.2. in subparagraph the words "submissions and documents" with the words "registration of any particulars or documents submitted in support."
30. To supplement the provisions and paragraph 93.4.93.5. following: "93.4. or the owner of the registration applicant has not submitted to the national agency of medicinal products, in addition to the required documents or data and not explained his reasons for doing so;
93.5.13, this provision is not complied with the requirements referred to in point. "
31. Replace paragraph 109, first sentence, the words and figures "Commission Regulation (EC) no 1084/2003" with the words and figures "Commission Regulation No 1234/2008".
32. the express section 112.1. by the following: "112.1. take steps to ensure that the registration of the medicinal product and the manufacturer (if the owner of the registration is not a drug manufacturer) provide proof of medicinal products, their ingredients and the controls at an intermediate state of the manufacturing process, giving the description of the control methods used (this rule 11.1);".
33. the express section 114.2. the following wording: "114.2. the medicinal product is lacking in therapeutic efficacy. Therapeutic efficiency of the justification requirement does not apply to the homeopathic medicinal products registered in the simplified registration procedure; ".
34. To replace the words "in 114.4 such as declared in the" with the words "does not match that specified in the registration dossier".
35. The deletion of 114.7. section.
36. Supplement with 114.8. subparagraph by the following: "registration is received 114.8. owner's application."
37. To supplement the provisions of the following paragraph 114.1: "this rule 114.1 paragraph 114 decision shall enter into force on the date of adoption of the decision."
38.118 points to express the following: "118. Medicine State Agency shall adopt a decision to cancel the rules referred to in paragraph 114 of the decision on registration or re-registration suspension, if the circumstances which were the basis for a decision."
39. To complement the 120.4.2. subparagraph after the word "records" with the words "as well as notify you of any prohibition or restriction imposed by the other competent authorities of the country in which the product is distributed, and other new information that may affect the drug benefit and risk assessment".
40. the express section 122.4. by the following: "health economics 122.4. notify the Centre and health system regarding this provision adopted 9., 11., 14., 114 and 118. decisions referred to in points and decisions, which have lost power in accordance with the provisions of paragraph 125;".
41. The deletion of section 122.5., the words "and the Ministry of health".
42. The deletion of the introductory part of paragraph 125, the words "or registration".
43. To complement section 125.1. in the second sentence by the following:

"This does not apply to the case where at least one form of marketing of the medicinal products in the distribution packages in Latvia;".
44. To supplement the provisions under section 125.3. and 125.4. the following wording: "the owner of the registration is 125.3. told the State Agency of medicines of the suspension of distribution of medicinal products in the Republic of Latvia;
125.4. the entry into force of the decision on refusal of renewal. "
45. To supplement the rules by 125.1, 125.2 and 125.3 points as follows: "the State Agency of medicines of 125.1 may decide not to apply this provision to 125.1 and 125.2.. the rules referred to the period from one year to three years, taking into account the application of the owner of the registration, based on public health considerations (annex 9).
the owner of the Registration rules 125.2 of 125.1 application referred to in paragraph 1, the State Agency of medicines shall be submitted not later than three months before this rule and section 125.1.125.2. the end of this period.
the State Agency of medicines of 125.3 30 days after these regulations referred to in paragraph 125.1 due receipt of the application of the administrative procedure law submission of assessed that basis and shall take a decision on these rules or 125.1.125.2. the provisions referred to in the application or non-application and inform the holder of the registration. The State Agency of medicines information for the immediately public Web site (http://www.zva.gov.lv). "
46. Make the following introductory paragraph 127: "127. to provide that the opinion referred to in paragraph 6, the State Agency of medicines of the product evaluation is entitled to request from the product manufacturer, Distributor, or authorized persons the following particulars and documents:".
47. To supplement the provisions of this subparagraph with 127.8.: "127.8. other informative materials on the evaluated product."
48. To supplement the rules with 127.1, and point this 127.3 127.2: "assessing the characteristics of the product 127.1, the State Agency of medicines shall take into account: 1. the product 127.1 qualitative and quantitative composition;
2. product 127.1 pharmacological, immunological and metabolic characteristics, in so far as they are under current scientific knowledge can find out;
3. use-127.1 types, as well as the fact, or a similar product composition has been registered as a medicinal product;
127.1 4. product information (such as marking, instructions for use);
5. product visibility of 127.1 to consumers;
127.1 6. risks that may result from the use of the product.
127.2 medicine State Agency evaluated products and the provision of paragraph 6 of that opinion to the applicant, providing data and document evaluation within two months after this provision in paragraph 127 of the receipt of the information.
127.3 medicine State agency information about this rule referred to in paragraph 6 of the opinion no later than the day following the sending of the opinion of the electronic document in the form of: 1. the health inspection for the 127.3;
127.3 2. Food and veterinary service, if the opinion delivered by the food and veterinary service initiatives;
127.3 3. Environmental State inspection, if the opinion delivered by the State environment inspectorate initiatives. "
49. Delete paragraph 128 and 129..
50. paragraph 136 be expressed as follows: "136. Registration certificate, issued by the State Agency of medicines to the date of entry into force of the provisions, they are valid until the expiration date, except that rule 125 paragraph."
51. the supplement to Chapter XV, paragraph 140.141 and by the following: "140. Submitting that rule 16, 49, 61, 65, 84, 95. and application referred to in paragraph 125.1 and accompanying data and documents (the registration dossier) electronic document, by the appropriate laws and regulations for the design of electronic documents. If the original documentation was submitted in electronic form of a document, this provision 16, 49, 61, 65, 84 and 95 of the registration referred to in paragraph a is entitled to submit documentation electronically in accordance with the provisions of 23.1. section.
141. valid notices that laid down in Commission Regulation (EC) no 1084/2003 and article 5 applications for changes in the mutual recognition procedure and the decentralised procedure established medicinal product which is submitted to it in accordance with the provisions of chapter XIII to 2010 January 1, according to the Commission Regulation No 1234/2008 article 27 paragraph 2. "
52. Make informative reference to European Union directives, paragraph 1 by the following: "1) of the European Parliament and of the Council of 23 April 2009. directive 2009/35/EC on the colouring matters which may be added to medicinal products;".
53. Make annex 1 as follows: "annex 1 cabinet may 9 2006, regulations No 376 of the Republic of Latvia REPUBLIC OF LATVIA's State Agency of medicines of the State AGENCY OF medicines (address, registration number, telephone number, fax number) (address, registration number, phone, fax number) registration certificates for the MARKETING AUTHORIZATION OF the MEDICINAL product in Riga/Riga Nr./No._____ drug name, strength, pharmaceutical form of the name of the medicinal product , the strength, the pharmaceutical form, the name of the active substance in the name of the active substance information on packaging package information the registration certificate holder of the Marketing authorization holder the decision to register/reregister the medication Decision on authorization/renewal in force until Valid until the decision to approve changes to the Decision on approval of the National Medicines Agency variation of a responsible officer of a Responsible official of the State Agency of medicines (signature) (signature) (position, name, surname) (position, name, surname) Z.v. Seal date _____ _____ _____ _____ ". 54 Data to delete the annex 2.
55. Express 3.43.2.3. subparagraph by the following: "43.2.3. to indicate the international colouring (E) the number, which corresponds to the list of food additives colourant in accordance with laws on minimum safety requirements for food additives."
56. Express 3.46.1.) (fourth and fifth sentence the following wording: "colours meet the regulations on minimum safety requirements for food additives permitted in food additives list colours. Purity criteria for colours meet the regulations on minimum safety requirements for food additives food additives set out purity criteria; ".
57. Make chapters of Annex 8 "small type I A and I B changes" table 34 "conditions" box 5. conditional as follows: "5. the All new components must comply with the legislation on minimum safety requirements for food additives permitted in food additives list the colours."
58. Replace annex 8. "notes" in paragraph 5 the words and figures "of the European Commission of 3 June 2003, Regulation (EC) No 1085/2003 concerning the examination of variations of a marketing authorisation for medicinal products for human use and veterinary medicinal products covered by the conditions of the regulation laying down a Community procedure for how to confirm and monitor the medications that are intended for use in humans and in veterinary medicine, and establishing a European Medicines Agency" with the words and figures "Commission Regulation No 1234/2008".
59. To supplement the provisions of Annex 9 to the following: "9. the Cabinet of Ministers may 9 2006, regulations No 376 Submissions in accordance with the Cabinet's May 9, 2006 no. 376 of the provisions of the registration of the medicinal product" order "in the Application of paragraph 125 Accordanc with clause 125 of the Cabinet of Minister's Regulation No. 376 Product Registration procedure" Medicinal "mAh/Marketing authorization holder name/name/address/postal code/Town/City Postal code contact person/contact person/phone number/Country phone email address/E-mail address
Medications, which for three years has been the Latvian market with at least one of the packages the medicinal product that has not been placed on the Latvian market within three years with at least one packaging information on medicinal products/Drug Information on medicinal product name/product name Medicinal strength, shape/form the Strengh, registration No./Marketing authorization From.
 
 
 
 
Exclusive rights in the grounds (in accordance with Cabinet of Ministers 9 May 2006 no. 376 of the provisions of the "medicine" procedures for registering 125.3)/Justification for exemption/(in accordanc with sub-clause 125.3 of the Cabinet of Minister's Regulation No. 376 Product Registration procedure "Medicinal" grace period/extension possible exclusive rights may apply to the product, which can lead to the absence of risk to public health and that the Latvian register of medicinal products have two or fewer analog (taking into account the ATC codes , indications, route of Administration) there is a lack of an alternative medicinal products suitabl which means that there is a potential for adverse impact on public health and the medicinal product has two or fewer analogu in the Register of Medicinal products of the Republic of Latvia (in view of ATC codes, indication, route of administration 3 years/3 years exclusive rights can be applied to medicinal products that is part of the national material reserves medications in accordance with the laws and regulations on emergency medical provision and pretepidēmij measures, medication preparation and security system work in case of danger the country

The medicinal product is a part of the national reserve of medicinal products in accordanc with regulatory enactment on ensuring emergency medicinal AIDS and anti-1987 ", development of medicinal product provision system and works in case of threat to State security 3 years/3 years exclusive rights can apply to medicines for legal exports to third countries, the medicinal product is intended for certified export to non-EEA countries (third countries) 3 years/3 years exclusive rights can be applied to medicinal products established in the mutual recognition (MR) or decentralised (DC) registration procedure as a reference country (possibility of distribution of medicinal products for the participating Member States) the medicinal product has been mutually recognised through the mutual recognition (MR) or decentralized (DC) procedure with Latvia as RMS (the supply of medicinal products ensur in participating Member States) 3 years/3 years exclusive rights can apply medicine cases If the production is planned for the site or process changes, and a valid registration certificate is required in order to provide patients with medicines the medicinal product for which there is an on-going the planned change in manufacturing site or process authorization is required to validate and marketing the patient will ensur with the medicinal product 1 year/2 years the applicant certifies that the information provided in the application is correct and the supporting rationale will be submitted within a week of the State Agency of medicines.
The applicant's declare that the above information is correct and that evidence justifying the above claims will be provided within one week of any request by the State Agency of medicines signature/signature name, surname/name, surname date/date notes.
1. the Meeting of the European Parliament and of the Council of 6 November 2001 of Directive 2001/83/EC article 4, 5 and 6 point (In accordanc with clause 4, 5 and 6 of article 24 of Directive 2001/83/EC of the European Parliament and the Council as of 6 November 2001).
2. the document properties in the "signature" and "date" does not fill in, if an electronic document is drawn up according to the law on electronic document design. "
Prime Minister, Minister of finance e. Repše Health Minister d. Gabor