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/88939

 
Cabinet of Ministers Regulations No. 401 of 2004 in Riga on April 22 (Mon. No 24, § 37) for medicinal products for veterinary pharmacovigilance procedure Issued in accordance with article 5 of the pharmaceutical law of point 6 (I). General questions 1. determines the order in which the veterinary medicinal product to use the monitoring of potential side effects.
2. the rules relating to the side effects caused by: animals: 2.1 2.1.1. the use of veterinary medicinal products (including animal healing therapeutic attached to feed premixtures;)
2.1.2. medicines used in veterinary medicine for the people;
2.1.3. the use of veterinary medicinal products not according to the labelling of the veterinary medicinal product and the information specified in the instructions for use;
2.2. people — occasional veterinary medicinal products or their use;
2.3. — going into veterinary medicines in the environment (pollution);
2.4. no veterinary medicinal product;
2.5. changes in release of veterinary medicinal products from the body.
II. Arrangements for the movement of veterinary medicinal products stakeholders report adverse reactions observed 3. The veterinarian animal owner or other person involved in the movement of medicinal products (hereinafter referred to as the Rapporteur) may report: 3.1 for unexpected side effects (undesirable phenomenon that occurs when entering the animal medicine instructions dosage medications for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function of the organism) becomes known to it, or use of the veterinary medicinal product for human use or the performance of their professional duties , including: 3.1.1. potential serious adverse reactions (side effects, which result in death or which causes serious health disorders, presents a threat to animal life, is a congenital anomaly of the treated animal or prolonged signs);
3.1.2. possible adverse side effects (adverse reaction, the nature, severity or outcome of which is not consistent with the description of the medication);
3.2. of side effects (adverse reaction, the nature, severity or outcome of which matches the description of the medication) that it becomes known, or use of the veterinary medicinal product for human use or the performance of their professional duties. Evaluation of received messages, the food and veterinary service determines the drug side effects frequency specified in the instruction;
3.3. for any possible unwanted side effects people (unwanted human body reactions that are observed after the man had exposure to a veterinary medicine), which probably led to the veterinary medicinal product;
3.4. If the veterinary medicinal product, adverse effects on the environment; 3.5. If the veterinary medicinal product is not effective.
3.6. If the veterinary medicinal product changes during the withdrawal from the body.
4. where the Rapporteur finds: 4.1. This provision 3.1. and 3.2. side effects referred to the animal or group of animals, it fills in the message form (annex 1) and sends it to the food and veterinary service;
4.2. no veterinary medicinal product efficacy, it fills in the message form (annex 1) and sends it to the food and veterinary service;
4.3. the rules referred to in point 3.3 side effects people or group of people, it fills in the message form (annex 2) and forward it to the food and veterinary service;
4.4. veterinary medicines adverse environmental impacts, it fills in the message form (annex 3) and send it to the food and veterinary service;
4.5. the presence of antibiotic residues in milk, it fills in the message form (annex 4) and sends it to the food and veterinary service.
III. The veterinary medicinal product, the holder of the registration certificate (the owner's) responsibilities 5. The veterinary medicinal product, the holder of the registration certificate (the owner) about the side effects of man or animal, which observed the use of the veterinary medicinal product by the holder of the registration certificate (the owner) the registered veterinary drug, reported to the officer.
6. The veterinary medicinal product, the holder of the registration certificate (the owner) shall designate the officials responsible for which you have the appropriate qualifications and is responsible for veterinary medicinal products registered.
7. the provisions referred to in paragraph 6 of the officer responsible for the maintenance of the data system which collects all the information provided in the operator's staff, representatives or distributors on the holder of the registration certificate (the owner's) veterinary medicinal products registered for possible dangers side effects in humans or animals, and which become known from veterinarians or other movement of veterinary medicinal products by the person concerned or from post-marketing studies of veterinary medicinal products.
8. the Provisions of paragraph 6 of the said responsible official: 8.1 immediately recorded the provision referred to in paragraph 7 data system received information about potential side effects;
8.2. immediately notify the food and veterinary service of known side effects and no later than 15 days shall send written information on them;
8.3. preparing periodic safety reports (annex 5), showing the latest data on the safety of the medicinal product, which also includes a scientific assessment of the veterinary medicinal products registered in the utility and risks;
8.4. those provisions 8.3. referred to in the periodic security report to the food and veterinary service: 8.4.1. every six months, if the period which elapsed between the registration certificate of the veterinary medicinal product, is less than two years;
8.4.2. once a year, if the period which elapsed between the registration certificate of the veterinary medicinal product, is more than two years;
8.4.3. simultaneously with documents for renewal of registration (renewal);
8.4.4. the food and veterinary service request, if the medicinal product is registered (re carried out) for more than five years ago or five years interval, together with the application for the registration of veterinary medicinal products, extension of validity of the certificate.
9. The veterinary medicinal product, the holder of the registration certificate (the owner) by the food and veterinary service request immediately provided the following additional information: 9.1 on veterinary medicines and prescriptions in the sales of the prescription;
9.2. for post-registration safety of veterinary medicinal products studies;
9.3. the veterinary medicinal product-related adverse reactions or failure;

9.4. withdrawal period for compliance with the registration information in the documentation;
9.5. for the assessment of adverse reactions by A, B, O and N code (hereinafter referred to as a SUBSCRIBER to the code), in which: (A) code 9.5.1 indicates a message about the side effects of side effects, which may have been caused by the use of the product specified in the report;
9.5.2. with (B) the code represents a message about side effects when administered to the animal more drugs and cannot determine which of the products indicated in the message causes side effects. Medicinal products for which the report is considered to be drugs that have potential side effects, but other drugs, which are also used in the treatment as a possible side effect of causing factors;
9.5.3. with this code indicates a message about the side effects, 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;
9.5.4. the N code indicates a message about the side effects, if animal tests (the test) shows that the use of the veterinary medicinal product has no side effects, or it is unlikely that the message contains the Hall have caused side effects.
10. If the veterinary medicinal product is distributed in Latvia and beyond, the veterinary medicinal product, the holder of the registration certificate (owner): 10.1. maintain this rule 7, paragraph data system and collects the information on Latvia and other countries perceived potential side effects. The data system is available in at least one location in the territory of the European Union;
10.2. this rule 8.3. referred to in subparagraph periodic security report information about any side effects that registered outside Latvia;
10.3. immediately notify the European Agency for the evaluation of medicinal products, the food and veterinary service and other competent authorities of the country in which the veterinary medicinal product is registered on the perceived potential for serious adverse reactions in animals or humans, and not later than 15 days send a written message with detailed information.
11. In the case of veterinary medicinal products registered: 11.1. centralized registration procedure, the veterinary medicinal product, the holder of the registration certificate (the owner) immediately notify the European Agency for the evaluation of medicinal products (created in accordance with the Council's 22 July 1993, Regulation (EC) No 2309/93 relating to procedures to be carried out within the community in veterinary medicinal products for human use and registration and monitoring, as well as the order in which it is established the European Agency for the evaluation of medicinal products) for any perceived serious unexpected adverse reactions, and not later than 15 days shall forward a written report with detailed information about them;
11.2. using the mutual recognition procedure, the registration certificate of the veterinary medicinal product holder (owner) agreed with the competent national authority and the food and veterinary service of time intervals, which will be reported on any perceived serious unexpected adverse side effects in animals.
IV. information of the veterinary medicinal product by the holder of the registration certificate (the owner) sent to the food and veterinary service, if the adverse effect of using its registered veterinary medicine 12. If the veterinary medicinal product, the holder of the registration certificate (the owner) heard from the rapporteur's report, or if side effects found in post-registration testing of veterinary medicinal products, it shall send the food and veterinary service periodic security report (annex 5), and in addition to the report indicates (in free form) information in six sections in accordance with these rules 13, 14, 15, 16, 17, 18 and 19 above.
13. The provisions of paragraph 12 of the report referred to in the first section: 13.1 the official name, which is responsible for the registration certificate of the veterinary medicinal product by the holder of the registered drug side effects;
13.2. the responsible address, phone and fax numbers;
13.3. report number, allocated by the designated officer;
13.4. the date that the officer received the message;
13.5. the message source (clinical or post-registration studies, distributor of veterinary medicinal products, veterinary or other movement of veterinary medicinal products by persons involved in adverse reactions found);
13.6. the rapporteur's name, address, occupation, and also, if possible, submit a copy of the report;
8.5. the country found side effects;
13.8. the importing of veterinary medicinal products.
14. the rules referred to in paragraph 12 of the report, the second section: 14.1. the number of animals treated;
14.2. the species, breed, age, sex and weight;
14.3. the observed symptoms.
15. the rules referred to in paragraph 12 of the report of the third section shows information about the medicinal products which may be the cause of the adverse reactions, as well as the following information: 15.1. name of the medicinal product;
15.2. the registration certificate of the veterinary medicinal product number;
15.3. the ATCve code (code anatomic therapeutic chemical codes);
15.4. the pharmaceutical form;
15.5. the medicinal product serial number and expiration date;
15.6. the instructions for storage of the medicinal product.
16. The provisions of paragraph 12 of the report referred to in the fourth section shows information about the treatment of animals: 16.1. the name, surname, occupation or qualifications, which entered the animal medicine;
16.2. the reason for the use of the medicinal product and diagnosis;
16.3. the entered drug dose and interval (if the product repeatedly entered), route of administration and location;
16.4. the first date of the drug;
16.5. the date when the last of the medicinal product, as well as the duration of the use of the medicinal product;
16.6. the symptoms the time interval between the administration of the medicinal product (if there is);
10.4. action following the detection of unexpected symptoms (for example, drug dose reduction or other medicines);
16.8. indication of whether such symptoms have been found before. If symptoms are detected early, specify the following information: 16.8.1. date on which the animal was already entered this medicine;
16.8.2. the description of the symptoms;
16.8.3. treatment results.
17. The provisions of paragraph 12 of the report referred to in the fifth section shows information on the other at the same time, the medicines used (medication used simultaneously with the medicinal products presented in report). This section also shows during the week used medicines, when seen side effects. For every parallel medicines used specifies the following information:

17.1. the name of the medicinal product, the ATCve code (code anatomic therapeutic chemical codes) and the pharmaceutical form;
17.2. the serial number (if the product is not made in a drugstore), expiry date and instructions for the storage of medicinal products;
17.3. information about: 17.3.1. the person who entered the Hall to the animal;
17.3.2. dose and the time interval between dose, route of administration and location;
17.3.3. the date of the start and end for the medicine to animal.
18. The provisions referred to in paragraph 12 of the report of the sixth section shows information about the side effects observed: 18.1. side effects;
18.2. side effects of detection date and time;
18.3. side effects (symptoms caused by) the date and time of the disappearance;
18.4. the treatment, carried out in order to prevent side effects.
19. the rules referred to in paragraph 12 of the report of the seventh section shows information on tests and studies carried out to investigate the cause of the adverse reactions identified: 19.1. If death occurred, indicate all the possible causes of death. If made in the laboratory or other tests and post-mortem examinations, test and examination results, the document sent to the food and veterinary service;
19.2. If tested samples of medicinal products, the results of the investigation added to the documents sent to the food and veterinary service;
19.3. If these provisions have been taken to 19.1 and 19.2. the studies referred to, specify the appropriate type of investigation reported.
V. food and veterinary service obligations 20. food and veterinary service shall take measures to encourage the reporting of potential side effects caused by the use of a veterinary medicinal product or a medicinal product for human use of animals.
21. food and veterinary service cooperates with the European Agency for the evaluation of medicinal products, to: 21.1. facilitate the exchange of information regarding activities detected possible causes of adverse reactions to veterinary medicinal products and monitoring;
21.2. create a unified data-processing network for the European Union registered veterinary medicinal products;
21.3. facilitate the exchange of pharmacovigilance of medicinal products in the European Union, as well as participate in the development of the guidelines (guidelines) for: 21.3.1. procedure can collect, verification and presentation of the reports of the veterinary medicinal product-related adverse reactions;
21.3.2. the technical requirements to be met through the exchange of information, as well as on the procedures for the use of electronic information tools, where the information is provided, using internationally accepted terminology.
22. The food and veterinary service creates and maintains a pharmacovigilance of the veterinary medicinal product monitoring system and: 22.1. collects information on drug induced reactions in humans and animals, scientific evaluation, it is compared with the data on the sales of veterinary medicines and prescription of prescriptions;
22.2. collects information about veterinary medicine: 22.2.1. inefficiencies;
22.2.2. use inappropriate labelling of medicinal products and the information specified in the instructions for use;
22.2.3. tests or studies carried out to verify the registration documents in the specified withdrawal period (withdrawal from the body) compliance with labelling and instructions for use given information;
22.2.4. potential (potential) environmental impacts; 22.3. veterinary medicinal products evaluated by the holder of the registration certificate (owner) posted information (including on the usefulness of the veterinary medicinal product or risks);
22.4. evaluate reports of side effects by using the SUBSCRIBE code.
23. The food and veterinary service provides the following: 23.1. these terms referred to in paragraph 22 of the monitoring system;
23.2. message forms of information processing on the legislation on data protection;
23.3. the registration certificate of the veterinary medicinal product by the holder (owner) information on adverse reactions that occurred by using his registered medicines, not later than 15 days after receipt of the report, as well as the exchange of data (if necessary), if the message contains the side effects, which are found on the veterinary medicinal product by the holder of the registration certificate (the owner) the registered use of the medicinal product;
23.4. personal data will not be divulged, if the rapporteur pointed out a message on the form;
14.6. the necessary data exchange using this provision 22, paragraph data exchange network, with other Latvian and international competent authorities, as well as, if serious adverse side effects in humans or animals, not later than 15 days after receipt of the report — a detailed report on the European Agency for the evaluation of medicinal products and other competent authorities of the countries in which the veterinary medicinal product is registered;
14.7. to the European Agency for the evaluation of medicinal products, the competent authorities of other States in which the veterinary medicinal product is registered, and the registration certificate of the veterinary medicinal product holder (owner) are immediately informed if, after monitoring data on veterinary medicinal products, the food and veterinary service considers that the need to suspend or to revoke a registration certificate of the veterinary medicinal product or to amend the registration of veterinary medicinal products given in the documents, information about indications, doses (Posology), animal species or breeds, or complete information on contraindications or precautions to be carried out, the use of the veterinary medicinal product to animals;
23.7. in the event that is considered urgent by the decision on the registration of the licence suspension. The decision taken not later than the next working day shall be notified to the European Agency for the evaluation of medicinal products, the competent authorities of other States in which the veterinary medicinal product is registered, and the registration certificate of the veterinary medicinal product holder (owner).
24. food and veterinary service: 24.1. checks if the veterinary medicinal product, the holder of the registration certificate (the owner), and the rapporteur has not provided information about the same event (or there is no duplication of information);
24.2. the annexes to these regulations provide the specified form;
24.3. classified side effects found. To adverse events classified as serious unexpected adverse side effects, take into account the species of animal for which the medicinal product is used:

24.3.1. pigs, birds, fish, bees, and other species of animals, where animals are kept and treated group, evaluated mortality factor. If the mortality rate is exceeded, the side effects are classified as serious unexpected adverse side effects;
24.3.2. horses, dogs, cats and other species of animals, if the animal is kept and treated individually, each animal's death classified as serious unexpected adverse side effects;
15.2. ensure that this provision of the annex 1 and 2 of that report form is yellow, 3. report form in annex a — green and annex 4 of this report in the form is pink.
Informative reference to European Union Directive provisions included in the law arising from the European Parliament and of the Council of 6 November 2001, Directive 2001/82/EC on the Community code for veterinary medicines.
Prime Minister i. Emsis Minister of Agriculture m. Roze Editorial Note: regulations shall enter into force by May 22, 2004.