The Registration Of Veterinary Medicinal Products Order

Original Language Title: Veterināro zāļu reģistrācijas kārtība

Read the untranslated law here: https://www.vestnesis.lv/ta/id/87997

 
Cabinet of Ministers Regulations No. 409 of 2004 in Riga on April 22 (Mon. No 24, 45) registration of veterinary medicinal products issued in accordance with article 5 of the law on Pharmacy (3) i. General questions 1. determines the order in which the food and veterinary service carries out the registration of veterinary medicinal products.
2. Authorized to distribute only those veterinary medicinal products, which the food and veterinary service is issued a certificate of registration of veterinary medicinal products.
3. The rules referred to in paragraph 2 of the veterinary medicinal product registration certificate is not required for veterinary medicinal products that have been registered with the European Agency for the evaluation of medicinal products (hereinafter referred to as the Agency) through the centralised procedure of registration (medicine whose registration is carried out in accordance with the Council of 22 July 1993, Regulation (EC) No 2309/93 relating to procedures to be carried out within the community in veterinary medicinal products and registration and monitoring, as well as the order in which it is established the European Agency for the evaluation of medicinal products) and in the case of veterinary medicinal products imported in accordance with article 12 of the law on Pharmacy 7.
4. it is prohibited to distribute and use of medicinal products not registered animals, except the physico-chemical, biological or microbiological, toxicological and pharmacological tests. These tests may be used only if their distribution and use and disclosure by authorized by the food and veterinary service.
5. Veterinary medicinal products (medicinal products) intended for use in animals from which foods are recorded only if their composition in active substances are specified in regulations, which defines the maximum allowable drug residues in food of animal origin.
6. food and veterinary service permission to distribute or use animals medicine under these regulations were registered by any other State, if it is necessary for health.
7. If the disease breaks out an epidemic and in the register of the veterinary medicinal product does not have the required medicines, food and veterinary service in accordance with the pharmaceutical Act may issue individual authorisations for immunological products not registered for distribution and use.
8. food and veterinary service shall inform the European Commission (hereinafter the Commission) when it performs this provision in section 7.
II. Procedures for submitting an application for the registration of veterinary medicinal products licence 9. for veterinary medicinal products, a certificate of registration, a person wishing to register a veterinary medicinal product (hereinafter applicant) shall submit an application to the food and veterinary service.
10. Veterinary medicinal products registration certificate may only be issued to the applicant, who is considered one of the countries in the European Union.
11. the application of these provisions, the applicant referred to in paragraph 9 shall be added to the application documents with the following information: 11.1. about the distribution of medicinal products, or the person responsible for the firm's traders and the persons responsible for the distribution of medicinal products in the actual or legal address. If the addresses are different, specify information about the manufacturer of a veterinary medicinal product or the manufacturer who is involved in the manufacture of medicinal products as well as information on the location of the production area and the actual address;
11.2. the name of the medicinal product, which may be: 11.2.1. mark;
11.2.2. non-proprietary drug name with or without a sign;
11.2.3. brand names;
11.2.4. a scientific name or formula, with or without a trademark, or brand names;
11.3. all veterinary medicinal products the active substance composition and ingredients of the qualitative and quantitative composition. Use common terminology, not empirical chemical formulas, as well as the international non-proprietary name recommended by the World Health Organization, where such name exists;
11.4. the veterinary medicinal product, the description of the manufacturing method;
11.5. the medicine therapeutic indications, contra-indications and adverse reactions;
11.6. the pharmaceutical form of the medicinal product, method, route of administration, the validity period and gave the animal species for which the medicinal product is intended;
11.7. instructions on the safety measures to be observed when storing or using medications for animals. Indicate any possible risk that medicine or treat animal excrement can cause to the environment and human, animal or plant health;
11.8. the period to which the product is released from the animal's body. If necessary, the applicant shall indicate the allowable drug residues in foodstuffs and proves that the specified levels do not pose a threat to the health of consumers. The results of the studies submitted with the routine test methods, to the food and veterinary service can use the residues of medicinal products;
7.4. the manufacturer's description of the control used (ingredients and finished product qualitative and quantitative testing, specific tests, such as sterility tests, tests for pyrogenic substances and heavy metal detection, drug stability tests, biological and toxicity tests and intermediate tests).
12. in addition to this provision, an application referred to in paragraph 9 shall be accompanied by the following documents: 12.1. on physico-chemical, biological or microbiological, toxicological and pharmacological tests and of clinical trial results;
12.2. one or more samples of medicinal products or advertising samples with instructions on the use of veterinary medicinal products;
12.3. a document showing that the manufacturer of the veterinary medicinal product is authorised in his own country to produce medicinal products.
12.4. veterinary medicinal products a copy of the registration certificate, certifying the registration of the medicinal product in other Member States of the European Union or a State which is not a Member State of the European Union (hereinafter third country), together with: 12.4.1. list of countries in which an application for registration of the licence is in the stage of the proceedings. The list of countries added to their copies of the document, which contains a summary of the characteristics of the veterinary medicinal product and the instructions for use provided with each of the countries listed in the list;
12.4.2. any negative decision in respect of the veterinary medicinal product, the issue of the registration certificate in the EU or in a third country with the motivation of the decision. This information shall be supplemented as soon as additional details of such decisions;
12.5. for that medicinal products containing new active substances which are not specified in the laws that determine the maximum allowable drug residues in food of animal origin, and that a copy is submitted to the Commission.
13. The applicant submits that rule 12.1. referred to test results, if he can prove that:

13.1. the application contains the veterinary medicinal product is almost identical to already registered medicinal products. The applicant is accompanied by a document stating that if the registered holder of the registration certificate of the medicinal product has consented to the consideration of the application documents for use in toxicological and pharmacological tests and clinical study results, which includes the registration file (documentation);
13.2. the components of the veterinary medicinal product or component has widespread veterinary practice and have proven that they are effective and safe. Specifies the detailed references to scientific literature;
13.3. the application contains the veterinary medicinal products are almost identical in the case of veterinary medicinal products in the European Union which have been registered for not less than six years, and that they are distributed in the Member State in which they are established. The food and veterinary service, issuing a decision, may extend this period to 10 years, if it considers necessary for the protection of public health, as well as you can not to apply the six-year period if it is expired patent that protects the original medicinal product;
13.4. the veterinary medicinal product is new, but the content is widely known constituents are used in therapy. The applicant shall provide the results of toxicological and pharmacological tests and clinical study results, but the documentation on each component of the veterinary medicinal product is not required.
14. a summary of the characteristics of the veterinary medicinal product shall bear the following information: 14.1. name of the veterinary medicinal product;
14.2. the active substance and excipients in the qualitative and quantitative composition (noted by the World Health Organisation, the international non-proprietary names recommended, if any, but if this name do not constitute non-proprietary or chemical names);
14.3. the pharmaceutical form;
14.4. pharmacological properties and, if the therapeutic effect proof requires: a pharmacokinetic particulars;
14.5. clinical data: 14.5.1. target species (animal species for which the medicinal product is intended);
14.5.2. indications for use the target species;
14.5.3. contraindications;
14.5.4. adverse reactions (frequency and severity);
14.5.5. Special precautions for the use of the medicinal product to animals;
14.5.6. the use of veterinary medicinal products for animals during pregnancy and lactation period;
14.5.7. veterinary medicinal product interaction with other medicinal products and other forms of interaction,
14.5.8. posology, the route of administration and, if necessary, action and symptoms in overdose (first aid, antidotes);
14.5.9. precautions to be observed in use, and target species for which the medicinal product is released from the body;
14.5.10. precautions to be taken by the person administering the medicinal product to animals;
14.6. pharmaceutical particulars: 14.6.1. major drug incompatibility;
14.6.2. the period of validity of the medicinal product, if necessary, instructions for the medicine of the medicine of the period of validity of the dilution or the container is opened for the first time;
14.6.3. special instructions for the storage of the medicinal product;
14.6.4. type of packaging and contents.
14.6.5. Special precautions for the disposal of unused medicinal products or waste materials, if any;
14.7. the holder of the registration certificate, the name or business name and the address or registered place of business.
15. food and veterinary service checks whether the expert with appropriate technical and professional qualifications has examined documents submitted by the applicant under this rule 11.9, 12.1 8..., and in paragraph 13. After the examination of documents signed by the expert and accompanied by documents which the applicant submitted to the food and veterinary service.
16. food and veterinary service make sure that expert has examined the application for the registration of veterinary medicinal products attached to documents according to the competence (analysis, pharmacology or equivalent experimental sciences, clinical trials). Expert in objectively describes the results of the qualitative and quantitative aspects and expressed in writing on the drugs tests carried out: 16.1 expert analyst determines whether the composition of the medicinal product meets the specified in the documentation submitted, if necessary, carry out control tests, as specified in the manufacturer's medicines control tests;
16.2 the expert farmakolog or equivalent qualified professionals evaluate submitted documents with information about: 16.2.1. drug toxicity;
16.2.2. the pharmacological properties of the medicinal product;
16.2.3. residues of medicinal products in foodstuffs of animal origin, if the product type for each target species in specified quantities. Assess whether the medicine residues may threaten the health of the consumer;
16.3. the expert clinical trial specialist will examine the documents presented on the therapeutic effects of the medicinal product and stating: 16.3.1. or treat animals were found to be specified by the manufacturer of the veterinary medicinal product in the therapeutic effects of the medicinal product;
16.3.2. do animals that used the Hall tolerated;
16.3.3. recommended doses and contraindications;
16.3.4. drug side effects, if any.
17. the expert reports are part of the documentation which the registration application, the applicant shall submit the application to the food and veterinary service. Each report shall be accompanied by a short biography of experts.
III. Procedures for registered veterinary homeopathic medicinal products 18. food and veterinary service: 18.1. check whether veterinary homeopathic medicinal products manufactured and distributed in the European Union, have been registered in accordance with these rules;
18.2. take account of the registration of veterinary medicinal products, and registration certificates issued by other Member States of the European Union.
19. food and veterinary service apply to the simplified registration of veterinary homeopathic medicinal products: 19.1 for the House (room) the animal or exotic animals (if they are not used in foodstuffs of animal origin);
19.2. method of use comply with European Pharmacopoeia or in the pharmacopoeia of the other (which is used officially in the Member States of the European Union) specified;
19.3. which label and in the instructions for use or in one of the documents submitted for registration does not specify specific therapeutic indications;

19.4. the percentage of which has a corresponding degree of dilution to guarantee the safety of the medicinal product. The medicinal product shall not contain more than one part of the 10000 (mother) tincture or more than one hundredth of the smallest dose used in the case of alopātij. If the concentration of the active substances is greater, the medicinal product in question to be supplied on veterinary prescription only and simplified registration procedure is not applicable for this product.
20. Registering veterinary homeopathic medicinal products, the food and veterinary service classifies its prescription or non-prescription (medications that are permitted to distribute without a prescription) medicinal products.
21. A Person who registers the veterinary homeopathic medicinal products, with the simplified registration procedures, the food and veterinary service shall submit the application. The application can include multiple series of veterinary homeopathic medicinal products which have been produced using the same raw material or feedstock.
22. registration of veterinary homeopathic medicinal products the applicant to certify veterinary homeopathic medicinal products quality and homogeneity produced the series (a series of identical medicinal products), the application shall be accompanied by the following documents: 22.1. document that mentioned raw materials or scientific name or name specified in the Pharmacopoeia, together with a description of the use of medicines, pharmaceutical forms and degree of dilution;
22.2. Description of the homeopathic stock or stocks is/are obtained, control and their homeopathic potency, based on bibliography. If the homeopathic veterinary medicinal product contains organic substances, a description of the measures taken to ensure that the product does not contain pathogenic micro-organisms;
22.3. the pharmaceutical form of each production and control;
22.4. dilution and potencēšan methods;
22.5. special permit (license) manufacture of homeopathic medicinal products for veterinary use;
22.6. in other Member States a copy of the registration certificate issued by the same homeopathic veterinary medicinal products;
14.1. the document certifying the stability of veterinary homeopathic medicinal products.
23. The rules referred to in paragraph 22 of the document adds one or more veterinary homeopathic medicinal products to be registered for the primary and secondary packaging samples or samples in their advertising.
24. The simplified registration procedure: 24.1. not applicable to veterinary homeopathic medicinal products intended for food-producing animals (animals, from which the foodstuffs of animal origin). Certificate of registration procedure for those homeopathic medicinal products is the same as for other veterinary medicinal products;
24.2. lasts 90 days from the date of the food and veterinary service has received the registration application and the documents specified in this section.
IV. Procedures for submission and consideration of registration to be issued a certificate of registration of veterinary medicinal products 25. food and veterinary service of veterinary medicinal products shall be issued a certificate of registration within four months from the date of receipt of these terms according to the design of the application for registration of veterinary medicinal products. If the registration application and the registration document to take longer, the food and veterinary service Director-General can be extended up to 210 days.
26. The food and veterinary service may stop a detailed consideration of the application, if the application for registration of veterinary medicinal products and are already considered in the other Member State of the European Union, and expect other European Member State of the Union message with a registration document.
27. food and veterinary service shall notify the Member State of the European Union and the applicant, if accepted this provision the decision referred to in paragraph 26 and requests the Member State of the Union message with a registration document.
28. If food and veterinary service, finds that a Member State of the European Union has issued the registration certificate of the veterinary medicinal product, where the registration of the food and veterinary service of the application has been filed, it may request the Member States of the European Union concerned to the competent authority a report on the registration document.
29. food and veterinary service, within 90 days after the European Union, the competent authorities of the Member State receiving the message: 29.1. The European Union recognized by the competent authority of the Member State of the decisions taken and the approved summary of the characteristics of the veterinary medicinal product;
29.2. the full registration procedure if the veterinary medicinal product can be dangerous to human or animal health or to the environment.
30. food and veterinary service of the application to look for registration of veterinary medicinal products presented in accordance with the provisions of 9, 10, 11, 12 and 13 points, and requirements: check the veterinary medicinal product, 30.1. registration application documents and expert reports, which were submitted in accordance with the provisions of paragraphs 16 and 17, included information;
30.2. you can send prepared veterinary medicinal product, its starting materials and, if need be, its intermediate products or other ingredients recognized laboratory investigation laboratory and verifies that the submitted documents for registration of medicinal products medicinal products specified by the manufacturer control techniques are sufficient for the quality control of veterinary medicinal products;
30.3. may require the applicant to provide additional information, if these rules 9, 10, 11, 12 and 13 listed in point a is not comprehensive. The registration period shall be extended until the food and Veterinary Office submitted the requested documents or, if required, the applicant will provide oral or written explanations to the questions arising from the examination of the submitted documents for registration;
18.9. may require the applicant to submit a food and veterinary service of the necessary quantities of the substance needed to verify the analytical methods specified by the applicant in the registration documents, as well as to be able to use these substances a routine tests for residues of the veterinary medicinal product concerned for the detection of residues.
31. If the registration application is filed concerning medicinal products produced in third countries, the food and veterinary service: 31.1. check that the manufacturer of the veterinary medicinal product in a pharmaceutical production methods meet the documents submitted for registration specified in the information provided in accordance with the provisions of section 11.4;

31.2. check that the manufacturer of a veterinary medicinal product can take the medicines control methods that are specified in the documents submitted to the registration of the medicinal product, in accordance with the provisions of paragraph 7.4.;
31.3. inspection of veterinary pharmaceutical company, if any of the manufacturing or control procedures (production of veterinary medicinal products, the company did not take full control of manufacturing or process) carried out by third parties.
32. The food and veterinary service shall issue a registration certificate of the veterinary medicinal product together with the approved summary of the characteristics of the veterinary medicinal product.
33. The food and veterinary service to the veterinary medicinal product, the holder of the registration certificate (the owner) on the registration certificate of the veterinary medicinal product to receive arbitrary does not change the information contained in the approved summary of the characteristics of the veterinary medicinal product.
34. The food and veterinary service sent to the Agency for veterinary medicinal products a copy of the registration certificate, together with the approved summary of the characteristics of the veterinary medicinal product.
35. The food and veterinary service presented in the evaluation report of the veterinary medicinal product, including comments on documents submitted for registration (including veterinary medicinal products made of the analytical and pharmacotoxicological tests and the clinical trials of the results). Evaluation report of the veterinary medicinal product is completed by the new information on the veterinary medicinal product, the quality, safety and efficacy, if one becomes available.
36. food and veterinary service of the veterinary medicinal product, the registration certificate holder (owner) may require that the primary or secondary packaging and instructions on the use of veterinary medicinal products (hereinafter referred to as the manual) should contain information about the precautions for the use of the medicinal product, animal, or other health or safety information that has become known by the pharmacological tests or the results of clinical trials of medicinal products for veterinary use or practice.
37. the registration certificate of the veterinary medicinal product, you can specify that the composition of the veterinary medicinal product does not need to include the contrast medium.
38. In exceptional cases, an objective and verifiable reasons the food and veterinary service, after consultation with the veterinary drug registration applicant shall be issued a certificate of registration if registration of veterinary medicinal products, the applicant agrees to assume the following responsibilities: 38.1. each year, submit a report on the research of the veterinary medicinal product by the continuation of the registration certificate of the veterinary medicinal product;
38.2. the report on the dangers of veterinary medicinal side effects.
39. After the registration certificate of the veterinary medicinal product to the receive the holder (owner) of the veterinary medicinal product control methods are supplemented in the light of scientific and technical progress to the veterinary medicinal product to be manufactured and tested according to the generally accepted scientific methods. On the changes of informēPārtik and veterinary services, who shall examine and approve.
40. If food and veterinary service requires that the veterinary medicinal product, the holder of the registration certificate (the owner), in the light of scientific and technical progress, review the registration documents indicate the analytical method and make possible improvements.
41. The veterinary medicinal product, the holder of the registration certificate (the owner) immediately inform the food and veterinary service, if: 25.5. new information becomes available which may require amendments to the registration documents or in the approved summary of the characteristics of the veterinary medicinal product;
41.2. a national competent authority has banned this medication or established limits;
41.3. serious adverse effects not animals or people, using the registered veterinary medicinal products.
42. The veterinary medicinal product, the holder of the registration certificate (the owner) lists established by the veterinary medicinal product and the possible (animals or humans observed) side effects. Accounting shall be kept for at least five years after the last entry and shall produce food and veterinary service regulations for pharmacovigilance of the veterinary medicinal product surveillance.
43. The veterinary medicinal product, the holder of the registration certificate (the owner) immediately inform the food and veterinary service, if necessary, amendments to the registration of veterinary medicinal products, documentation or the certificate of registration of veterinary medicinal products.
44. the certificate of registration of veterinary medicinal products shall be valid for five years.
45. the registration certificate of the veterinary medicinal product to re-register after five years, if: 45.1. the veterinary medicinal product, the holder of the registration certificate (the owner) submits an application for at least three months before the registration certificate of the veterinary medicinal product expiry date;
45.2. The food and veterinary service checked the documentation for registration of veterinary medicinal products, including the previously submitted information.
46. The veterinary medicinal product, the issue of the registration certificate does not relieve the manufacturer of the veterinary medicinal product concerned and the holder of the registration certificate (the owner) the legal responsibility.
47. the certificate of registration of veterinary medicinal products shall be issued if, in considering the registration of veterinary medicinal products, the documents submitted establishes that: 29.3. the veterinary medicinal product is harmful in the registration documents in the specified form;
47.2. the veterinary medicinal product is not listed in the registration dossier or therapeutic effect the applicant has not provided sufficient proof of such effect registration documents specified in the target species of animal;
47.3. the veterinary medicinal product, qualitative or quantitative composition is not as stated in the registration documents;
47.4. the registration application, the recommended withdrawal period for veterinary medicinal products: the 47.4.1. is not long enough to ensure that derived from animals treated food products of animal origin do not contain residues of medicines consumer health dangerous quantities;
47.4.2. are inadequate;
29.5. the intended use of the veterinary medicinal product is prohibited in the territory of the European Union;
29.6. the veterinary medicinal product can be dangerous to the public, consumer or animal health;
29.6. the documents submitted for registration does not comply with the requirements laid down in these provisions.
V. procedures for veterinary medicinal products registered via the mutual recognition procedure 48. Agency:

29.9. examine any questions concerning the registration of veterinary medicinal products, the granting of the licence, amendment (change) the suspension or withdrawal;
48.2. shall examine any question concerning the testing of veterinary medicinal products.
49. prior to the application for registration of veterinary medicinal products through the mutual recognition procedure, the registration certificate of the veterinary medicinal product holder (owner) shall inform the Member State of the European Union, which issued the certificate of registration of veterinary medicinal products (hereinafter referred to as the reference Member State).
50. The veterinary medicinal product, the mutual-recognition procedure the applicant reported to the food and veterinary service of all registration documentation additions. The food and veterinary service may require the applicant to provide the necessary information and documents to be able to check the identity of the dossier submitted to the reference Member State submit the registration dossier.
51. The veterinary medicinal product, the holder of the registration certificate (the owner) the reference shall request the Member State concerned within 90 days to prepare an assessment report on the veterinary medicinal product and, if necessary, restore the information in it.
52. where a food and veterinary service is received by the reference Member State shall prepare a report of the evaluation of veterinary medicinal products, veterinary medicinal products, the holder of the registration certificate (the owner) may submit an application for the registration of veterinary medicinal products through the mutual recognition procedure.
53. The rules referred to in paragraph 52 of the applicant: 53.1. the application of these rules 9, 10, 11, 12, 13, 14, 32, 33, 34 and 35. referred to in paragraph 1, the information and documents;
53.2. confirms that the documentation is identical to the reference Member State the documentation submitted;
53.3. indicate possible additions or amendments necessary to reference the documentation submitted to the Member State;
53.4. certify that the summary of the characteristics of the veterinary medicinal product is identical to the approved reference Member State;
13. confirm the food and veterinary service of the documents of identity documents submitted for registration reference Member State;
53.6. transmit to the Agency a submission for registration of veterinary medicinal products through the mutual recognition procedure and: 53.6.1. indicate the Member States of the European Union, which it is submitted;
53.6.2. indicate the date of submission of the application;
53.6.3. send the reference Member State Veterinary Medicine issued a copy of the certificate of registration;
53.6.4. send it to the Member States of the European Union issued the registration certificate of the veterinary medicinal product, where a copy of the veterinary medicinal product is registered;
53.6.5. specify a member of the European Union, in which the registration document and the application is located.
54. The food and veterinary service: 54.1. the reference Member State shall issue the certificate of registration of veterinary medicinal products recognised within 90 days of this provision in the application referred to in article 52 and the reference Member State shall prepare the evaluation report of the veterinary medicinal product;
54.2. the decision taken shall inform the reference Member State, the Agency for veterinary medicinal products, the registration certificate holder (owner) and the other Member States of the European Union, which has filed this provision the application referred to in paragraph 52.
55. where a food and veterinary service considers that the veterinary medicinal product, the issue of the registration certificate may pose risk to human or animal health or the environment, it shall immediately inform the provision referred to in paragraph 52 the applicant, the reference Member State, the Agency and the other Member States of the European Union, which has filed this provision the application referred to in paragraph 52. The food and veterinary service detailed base their observations and indicate the required actions to correct possible gaps that rule application referred to in paragraph 52.
56. food and veterinary service: 56.1. agree with the participating Member States of the European Union on the action to be taken by this provision the application referred to in paragraph 52.
56.2. the applicant provide oral and written comments the opportunity to express their views;
56.3. report to the Agency if within 90 days of that rule 52 due receipt of the application referred to the inability to reach an agreement with the applicant and the other Member States of the European Union (which filed this rule application, paragraph 52) that the issue would be submitted to the Agency. The food and veterinary service will provide the Agency with a detailed description of the facts and the reasons for the dispute, send a copy to the applicant.
57. If the provisions of paragraph 55 cases of dispute and the applicant has received the 56.3. these provisions referred to a copy of the document, it sends the Agency a detailed presentation of their views and these rules 56.3. referred to a copy of the document.
58. where a food and veterinary service has received an application for the registration of veterinary medicinal products through the mutual recognition procedure, and other European Union Member States have adopted divergent decisions concerning the registration of the certificate of registration, suspension or revocation of a food and veterinary service, or the holder of the registration certificate refers the Agency identifies the problem and submit all the relevant information available.
59. food and veterinary service, depending on the Agency and the decision of the Commission after examining the case of a dispute may 28 days to send a written opinion on the draft Commission decision. Opinion of the Commission's food and veterinary service written opinion causes new important scientific and technological nature, which have not been addressed, document discussion and investigation continues.
60. food and veterinary department recognize this provision in paragraph 58 above, the registration of veterinary medicinal products if the Commission, having examined the information they deemed relevant European Union legislation.
61. The veterinary medicinal product, the holder of the registration certificate (the owner) who made the registration of veterinary medicinal products through the mutual recognition procedure, any amendments (changes) the registration certificate of the veterinary medicinal product which has been granted in accordance with the requirements of this chapter shall be submitted to all the Member States, which are recognised by the veterinary medicinal product concerned.
62. If food and veterinary service of human and animal health and the protection of nature, it is considered that:

62.1. requires amendments to the veterinary medicinal product, the registration certificate, issued in accordance with the requirements of this chapter, or the said certificate is required to suspend or revoke it immediately draws the Agency identifies the problem and submit all the relevant information available.
62.2. urgent action to protect human or animal health or the environment, that Latvia may suspend the certificate of registration of veterinary medicinal products in action, issued in accordance with the requirements of this chapter. The food and veterinary service no later than the next working day shall inform the Commission and the other Member States of the European Union, which is registered in the veterinary medicinal product in accordance with the requirements of this chapter. Such action is permissible only in exceptional cases.
VI. final question 63. provisions shall enter into force on 1 May 2004.
Informative reference to European Union Directive provisions included in the law resulting from the Council of Europe on 6 November 2001, Directive 2001/82/EC on veterinary medicinal products.
Prime Minister i. Emsis Minister of Agriculture m. Roze Editorial Note: rules shall enter into force on 1 May 2004.