Veterinary Pharmacovigilance Of Medicinal Products Order

Original Language Title: Veterināro zāļu izraisīto blakusparādību uzraudzības kārtība

Read the untranslated law here: https://www.vestnesis.lv/ta/id/155764

Cabinet of Ministers Regulations No. 246 in 2007. Riga on 10 April (pr. No 23 23) veterinary medicinal products, pharmacovigilance procedure Issued in accordance with article 5 of the pharmaceutical law of point 6 (I). General questions 1. determines the order in which made possible the use of veterinary medicines in pharmacovigilance (hereinafter referred to as the side effects of the veterinary medicinal product).
2. The terms used in the following terms: 2.1. side effects of the veterinary medicinal product, which is harmful and unintended reaction to a veterinary medicinal product that occurs when you enter the animals usual dose of veterinary medicinal products for the prevention, the diagnosis of disease, treatment or the modification of physiological function, adjustment or alteration;
2.2. for medicinal products for veterinary use – incorrect use of veterinary medicinal products that do not meet the description of the veterinary medicinal product, including the abuse of medicinal products for veterinary use and terms of use violations;
2.3. the use of veterinary medicinal products and the benefit-risk assessment of veterinary medicinal products in the therapeutic effect of positive evaluation in comparison with the use of a veterinary medicinal product risks;
2.4. the veterinarian's recipe-recipe for a veterinary medicinal product issued by a professional, who is entitled to do under the movement of veterinary medicinal products regulations regulatory requirements;
2.5. the unpredictable side effect-adverse reaction, the nature, severity or outcome of which is not consistent with the description of the veterinary medicinal product;
2.6. serious adverse reaction: a reaction which result in death or which causes serious health disorders, pose a threat to life, is a congenital anomaly or the treated animals to prolonged or permanent signs of disease;
2.7. the adverse reaction people – unwanted human body reactions that are observed after the exposure of the human exposure to a veterinary medicine;
2.8. the use of veterinary medicinal products for risk – risks associated with veterinary medicinal products, quality, safety and efficiency and which could affect the animal and human health, as well as the risks associated with the adverse effects of medicinal products on the environment; effects of expected 2.9-reaction, the nature, severity or outcome of which correspond to the description of the veterinary medicinal product.
3. in order to ensure coordinated decision making in the Member States of the European Union and European economic area countries (hereinafter referred to as Member States) izplatāmaj veterinary medicinal products, the State Agency of medicines shall establish and maintain a monitoring of adverse reactions to veterinary medicinal products (pharmacovigilance) system (monitoring system), taking into account the following information concerning veterinary medicinal products: 3.1 side effects observed;
3.2. the ineffectiveness of the veterinary medicinal product;
3.3. a misnomer;
3.4. the reliability research on retention time of veterinary medicinal products from the organism;
3.5. possible environmental problems that result from the use of veterinary medicinal products.
4. the monitoring system of the State Agency of medicines used to summarize and evaluate scientific information on the effects of the veterinary medicinal product, expression of human and animal body.
5. Monitoring system the information collected in the State Agency of medicines shall notify the competent institutions of the Member States and the European Medicines Agency, as well as the European Parliament and of the Council of 31 March 2004, Regulation (EC) No 726/2004 laying down the procedures for the authorisation and supervision of medicinal products for human and veterinary use Community procedures and establishing a European Medicines Agency, registered in the database.
II. a pharmacist and veterinary surgeon, veterinary medicinal products, the holder of the registration certificate (the owner's) responsibilities 6. To ensure the effective functioning of the monitoring system, the veterinary doctor or pharmacist (Rapporteur) in accordance with the provisions of the annexes to the report provide samples of informed the State Agency of medicines shall: 6.1. about unforeseen side effects that it become known, or use of the veterinary medicinal product for human use or performing professional duties (annex 1), including serious adverse reactions;
6.2. concerning the expected side effects that it become known, or use of the veterinary medicinal product for human use or performing professional duties (annex 1);
6.3. the unwanted side effects in humans, which may cause known in veterinary medicine (annex 2);
6.4. If the veterinary medicinal product, adverse effects on the environment (annex 3);
6.5. If the veterinary medicinal product, not efficiency (annex 1);
6.6. If the veterinary medicinal product changes during the withdrawal from the body (annex 4).
7. the rapporteur at the request of the State Agency of medicines shall provide the following additional information: 7.1 the withdrawal period for veterinary medicinal products match this registration information in the documentation;
7.2. the evaluation of the side-effects of the veterinary medicinal product in accordance with the A, B, O and N code (hereinafter referred to as a SUBSCRIBER to the code). SUBSCRIBE to code consists of the following expressions: 7.2.1.  A – report on the effects of the veterinary medicinal product, which may have been caused by the use of the product specified in the report;
7.2.2. B – report on the effects of the veterinary medicinal product, where an animal entered several medications and cannot determine which of the products indicated in the message causes the side effect. Medicinal products for which the report is considered medicinal products which are the side effects of the veterinary medicinal product may cause, but other drugs, which are also used in the treatment as possible side effects of the veterinary medicinal product-factor;
7.2.3. O – report on adverse reactions to veterinary medicinal products, if the message contains sufficient information about the medicine or physiological condition of the animal medicines and it is therefore not possible to assess the cause of the adverse reactions;
7.2.4. N-report on adverse reactions to veterinary medicinal products, if animal tests (the test) shows that the use of the veterinary medicinal product is not mentioned in the reports of adverse reactions to veterinary medicinal products, or it is unlikely that the message contains medicines caused by adverse reactions to veterinary medicinal products.
8. The veterinary medicinal product, the holder of the registration certificate (the owner) surveillance system: 8.1. designate the officials responsible for the veterinary medicinal product registered near the permanent monitoring of the phenomenon;
8.2. inform the State Agency of medicines of the Executive, announcing its name, qualifications, site address, telephone and fax numbers and electronic mail address.
9. the responsible officer is appropriately qualified (a doctor, veterinarian or pharmacist), permanently residing in Latvia and performs the following functions: 9.1. establish and maintain a data system which collects information about all the veterinary medicinal product, the holder of the registration certificate (the owner's) for veterinary medicinal products registered in the reactions with reported production of veterinary medicinal products the operator's staff, representatives or distributors and law on the advertising of medicinal products for veterinary professionals set the agenda;
9.2. prepares this rule 11.1 and 11.3 of the report referred to by the European Commission published guidelines on the next phenomenon supervision (hereinafter referred to as the guidelines of the European Commission);
9.3. upon request of the State Agency of medicines shall immediately prepare and provide any additional information that is needed for the use of the veterinary medicinal product benefit and risk assessment, including information on the sales of the veterinary medicinal product or prescription volume;
9.4. the State Agency of medicines shall provide any other information relating to the use of veterinary medicinal products the benefits and risk evaluation, including the information collected through post-marketing studies of veterinary medicinal products.
10. The veterinary medicinal product, the holder of the registration certificate (the owner) collects detailed information on the side effects of the veterinary medicinal product and report electronically in accordance with the instructions of the European Commission.
11. The veterinary medicinal product, the holder of the registration certificate (the owner) for veterinary medicinal products registered: 11.1. record the observed adverse effects in humans and severe adverse side effects: 11.1.1. veterinary medicinal products for which the holder of the registration certificate (the owner) has received information from a veterinarian, pharmacy, or other health care professionals;
11.1.2. in accordance with the instructions of the European Commission meet the reporting criteria and for which the veterinary medicinal product, the holder of the registration certificate (the owner) should be informed;
11.2. without delay, but not later than 15 days following the receipt of the information reported on this provision in paragraph 11.1. these phenomena near the State Agency of medicines or the competent authority in the Member State in whose territory the identified adverse effects of the veterinary medicinal product;

11.3. without delay, but not later than 15 days following receipt of the report all serious unwanted and unexpected side effects, unwanted side effects for people and for any possible cases of transmission of the infection to the mediation of the veterinary medicinal product in the territory of a third country national agency of medicinal products, the European Medicines Agency and the competent institutions of the Member States in which the veterinary medicinal product is authorised. The report presented and transmitted in accordance with the instructions of the European Commission;
11.4. the high technology level of the veterinary medicinal product (particularly logical Biotech for veterinary medicinal products) or, in the case of veterinary medicinal product on the market, the mutual-recognition procedure in accordance with the regulations on the registration of veterinary medicinal products, in addition to these rules, and 11.1 11.2 11.3. the requirements in paragraph about the unwanted side effects in humans and severe adverse side effects reported, the competent institution of the Member State in which the registration procedure for veterinary medicinal products prepared in this assessment report on veterinary medicinal products (hereinafter referred to as the reference Member State);
11.5. in accordance with the instructions of the European Commission, providing periodic security report (periodic reports on the safety of the veterinary medicinal product), report on adverse reactions to veterinary medicinal products by the National Agency for medicines, as well as in accordance with the regulations on the registration of veterinary medicinal products reported during clinical trials of the veterinary medicinal product of known side effects. In periodic safety reports, scientifically assess the effects on the use of veterinary medicinal products benefits and risks;
11.6. periodic safety reports submitted to the State Agency of medicines: 11.6.1. at least every six months after the registration certificate of the veterinary medicinal product and receipt to the placing on the market (if the regulations on the registration of veterinary medicinal products, the European Commission's instructions or otherwise);
11.6.2. at least every six months during the first two years following the initial placing of the veterinary medicinal product on the market and once a year for the next two years;
11.6.3. every three years, this provision and paragraph 11.6.1.11.6.2. those conditions are fulfilled;
11.7. by special request of the State Agency of medicines into the safety messages presented immediately;
11.8. the reporting of adverse reactions to the veterinary medicinal product, as well as the application of these regulations, shall act in accordance with the instructions of the European Commission and used internationally accepted medical terminology.
12. After the registration certificate of the veterinary medicinal product for veterinary use the granting of the registration holder (owner) is entitled to request to be reviewed this rule 11.6. the time limits referred to in accordance with the European Commission of 3 June 2003, Regulation (EC) no 1084/2003 concerning the examination of variations to the terms of a marketing authorisation, the competent authority of the Member State which issued for medicinal products for human use and veterinary medicinal products.
13. The veterinary medicinal product, the holder of the registration certificate (owner) prohibits the provision to the media for dissemination of information on the use of veterinary medicinal products authorised security if it has not been informed of the State Agency of medicines. The veterinary medicinal product, the holder of the registration certificate (the owner) provides the information bias. It should not be misleading.
III. duties of the supervisory body of the National Medicines Agency 14:14.1 provides as part of the monitoring system for the communication of information to other Member States ' competent authorities and the European Medicines Agency, as well as an introduction to the European Medicines Agency, the resulting database;
14.2. cooperate with the European Medicines Agency and the European Commission data-processing network, making it easy to create the monitoring system for the exchange of information on Member States izplatāmaj veterinary medicinal products, and to provide the competent authorities the opportunity to use relevant information;
14.3. using this rule 14.2 below. referred to in paragraph 1, the data-processing network, ensure that reports of Latvia the observed to veterinary medicines serious side effects immediately, but not later than 15 days following receipt of the report would be available for the European Medicines Agency, the other Member States ' competent authorities and the veterinary medicinal product, the registration certificate holder (owner);
14.4. this rule 11.4. veterinary medicinal products referred to in the analysis and monitoring of adverse reactions, if Latvia is the reference Member State;
14.5. is entitled to take a decision on the registration of veterinary medicinal products, the suspension of the licence for a period of up to half a year, if these rules are not respected, paragraph 13;
14. Authorizes the competent officials, who are trained to take good manufacturing practice compliance controls, test the veterinary medicinal product, the holder of the registration certificate (the owner) or the merchant premises and documentation, conducting surveillance of adverse reactions to veterinary medicinal products according to the requirements of this regulation.
15. If after evaluation of the monitoring system data in the State Agency of medicines shall decide on the registration certificate of the veterinary medicinal product in the suspension, cancellation or changes in the documentation for the registration of indications, doses (Posology), animal species or breeds, or information on contraindications or supplement the security measures carried out by the use of the veterinary medicinal product to the animals, it shall immediately inform the European Medicines Agency, the competent institution of the other Member States and the veterinary medicinal product by the holder of the registration certificate (the owner).
16. If it is necessary to carry out the urgent public and animal health measures, the State Agency of medicines has the right to suspend the certificate of registration of veterinary medicinal products. No later than the following working day of the relevant veterinary medicinal product, the suspension of the registration certificate and the measures to be taken and inform the European Medicines Agency, the European Commission and the competent authorities of the other Member States.
17. If you received a decision of the European Commission, which is based on the European Medicines Agency, prepared for the veterinary medicinal products which are distributed in the territory of Latvia, the State Agency of medicines shall take urgent distribution control measures and continue to act in accordance with the received decision.
18. the State Agency of medicines, pharmaceutical inspectorate and the State food and veterinary service according to competency control this enforcement.
IV. final question 19. Be declared unenforceable in the Cabinet of 22 April 2004, Regulation No 401 "veterinary pharmacovigilance of medicinal products order" (Latvian journal, 2004, nr. 81). 
Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 6 November 2001 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products;
2) of the European Parliament and of the Council of 31 March 2004, Directive 2004/28/EC amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
Prime Minister a. Halloween Minister of Agriculture m. Roze Editorial Note: rules shall enter into force on 14 April 2007.
   
1. the annex to Cabinet of Ministers 2007 10 April regulations no 246 report side effects to the animal (s) Minister of Agriculture m. Roze annex 2 Cabinet 10 April 2007 regulations no 246 report about dangers of veterinary medicines side effects people (s) Minister of Agriculture m. Roze annex 3 Cabinet 10 April 2007 regulations no 246 report on veterinary medicinal products, adverse effects on the environment, the Minister of Agriculture m. Roze annex 4 Cabinet 10 April 2007 regulations no 246 report on antibiotic residues in milk to the presence of the Ministry of Minister m. rose