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Cabinet of Ministers Regulations No. 919 Riga, 6 December 2005 (pr. No. 72 10. §) of pharmacovigilance procedure Issued in accordance with article 5 of the pharmaceutical law of point 6 (I). General questions 1. determine drug (excluding veterinary medicines) may use in pharmacovigilance (harmful and unwanted human body reaction resulting from the use of the medicinal product, according to the summary of product characteristics, disease prevention or treatment be adopted by Diagnosta, as well as the physiological function of the restoration, correction or modification of) (hereinafter referred to as drug side effects).
2. side effects of medicines monitoring system (hereinafter referred to as the supervisory system) designed to ensure consistent decision making on the European economic area (hereinafter referred to as Member States) of izplatāmaj, having regard to information obtained about the observed adverse reactions to medicinal products.
3. the monitoring system used to collect and evaluate scientific information about the adverse effects of the human body. The surveillance system is also used for any available information on drug misuse or abuse (regular or occasional intentional excessive use of medicinal products that cause harmful physical or psychological effect), which can affect the benefits of the use of the medicinal product and risk assessment. Risks of use of the medicinal product within the meaning of these rules is the risks associated with the drug quality, safety and effectiveness, and which may affect the patient's health or public health.
II. Medical person Pharmacy and drug registration certificate holder (owner) responsibilities 4. To ensure the effective functioning of the monitoring system, the medical and pharmacy in accordance with the provisions in the annex provide a sample of the report shall inform the State Agency of medicines of the medicines side effects: UR4.1.kas were the cause of death of the patient or the patient's life or occurrences which had required hospitalization of the patient's hospitalization or prolongation of, or caused by the patient's permanent or severe forms of disability or incapacity , or congenital abnormalities (birth defects) (hereinafter referred to as the essential drug side effects) and the medical people are aware, performing professional duties;
UR4.2.kas by nature, severity or outcome of which is not consistent with the summary of the product characteristics (hereinafter referred to as the unexpected side effects of the drug) and the medical people are aware, performing professional duties.
5. Medical and pharmacy at the request of the State Agency of medicines shall provide additional information on the observed drug side effects.
6. the registration certificate holder (owner) surveillance system designated a permanent Executive (staying in a Member State) with appropriate qualifications (doctor or pharmacist). The officer is responsible for the following functions: 6.1. establish and maintain a system containing information about all the side effects of medicines which are reported in the pharmaceutical company's personnel and the laws on drug advertising arrangements laid down by the medical representatives, and to ensure that this information is available in one place at least one Member State;
6.2. preparation of this provision the report referred to in paragraph 8, subject to the requirements laid down in the European Commission's recommendations, which are published by the European Commission European Community pharmaceutical legislative framework document inventory (hereinafter European Commission);
6.3. upon request of the State Agency of medicines shall immediately provide full (additional) information, including sales of medicines or discharge volumes that require the use of the medicinal benefits and risk evaluation;
6.4. to provide medicines to the Agency any other information related to the use of the medicinal benefits and risk assessment, including the farmak epidemiological or clinical research, made after registration to identify or quantify the medicinal product registered.
7. the registration certificate holder (owner) keep detailed records of all adverse reactions to the medicinal product, whether or not the side effects observed in a Member State or in a third country (the country where the non-Member State), and in accordance with the recommendations of the European Commission requirements in electronic form shall report on them.
8. the registration certificate holder (owner) in the case specified in the certificate of registration of medicinal products medicinal products: UR8.1.re ģistr in all territory of Latvia observed significant drug side effects, for which it became known from the medical or pharmacy, and immediately (no later than 15dien after receipt of information) that report on them to the National Agency for medicines;
ģistr and UR8.2.re immediately (no later than 15dien after receipt of information) shall report to the State Agency of medicines than any other in the territory of Latvia, observed the critical adverse reactions to medicinal products which, in accordance with the recommendations of the European Commission meet the reporting criteria and for which it should be known;
8.3. ensure that all the critical and unexpected drug side effects (adverse reactions of the medicinal product, which is both significant and unexpected according to this provision, paragraph 4) and for any possible cases of transmission of infection through a medicinal product in the territory of a third country in accordance with the recommendations of the European Commission to promptly, but no later than 15dien of receipt of the information reported to the European Medicines Agency and the competent institutions of the Member where this distribution is allowed;
8.4. in addition to these provisions 8.1., 8.2. and 8.3. the requirements referred to in point of high-technology medicinal products (particularly those derived from biotechnology) the placing on the market or the placing on the market of the medicinal products to which mutual recognition procedure for medicinal products in accordance with the regulations on the registration of medicinal products, also supports the following requirements – for all the critical reactions of the medicinal product in the Member State, of one of the observed are reported in such a way to make it available to the Member State who prepared herbal medicine assessment reports registration procedure (hereinafter referred to as the reference Member State), or to any competent institution that represents the reference Member State;
8.5. ensure the filed report on all medicine in recent years, the blakuspar State Agency of medicines according to the recommendations of the European Commission updated the security message periodically or immediately after the State Agency's request, or at least every six months after the receipt of the certificate of registration and until the placing on the market (if the legislation on the registration of medicinal products, no other requirements of registration the granting of the certificate or the recommendations of the European Commission unless otherwise specified). Periodically updated safety reports must be submitted immediately upon request or at least every six months, also for the first two years following the initial placing on the market and once a year for the next two years. Future reports must be submitted every three years, or immediately upon request. Periodic safety update reports shall include the use of the medicinal benefits and risks of scientific assessment. The use of the medicinal benefits and risks within the meaning of this provision is a positive therapeutic effects of the medicinal product evaluation compared to the use of the medicinal product hazards;
8.6. reporting on adverse reactions to medicinal products, as well as the application of these regulations, shall act in accordance with the recommendations of the European Commission and used internationally agreed medical terminology;
5.4. inform the State Agency of medicines of the rules referred to in point 6 of the officials responsible, indicating name, surname, qualification, site address, telephone and fax numbers, and electronic mail address.
9. After the granting of the registration certificate of the registration certificate holder (owner) is entitled to request to be reviewed this rule 8.5. time limits referred to in accordance with the European Commission of 3 June 2003, Regulation (EC) no 1084/2003 concerning the examination of variations, the competent authorities of the Member State of the issuing of a marketing authorisation for medicinal products for human use and veterinary medicinal products for conditions.
10. the registration certificate holder (owner) prohibits the provision of information to the general public on the distribution of authorised medicinal product safety if it has not been informed of the State Agency of medicines. Registration certificate holder (owner) shall ensure that the information provided would be impartial. It should not be misleading. If you do not comply with the requirements laid down in this paragraph, the State Agency of medicines has the right to decide on the registration certificates of the suspension for a period of up to half a year.
III. duties of the supervisory body of the National Medicines Agency 11:11.1. ensure supervisory system for the communication of information to other Member States ' competent authorities and the European Medicines Agency, as well as enter data of the European Medicines Agency created database;
11.2. cooperate with the European Medicines Agency and the European Commission to create a data-processing network to facilitate the supervisory system for the exchange of information on Member States and ensure izplatāmaj the competent authorities the opportunity to use relevant information;
11.3. using this rule 11.2. at the bottom of this data-processing network, ensure that reports of Latvia the observed the critical adverse reactions to medicinal products immediately, but not later than the following 15dien after receipt of the report would be available to the European Medicines Agency and the other Member States;
11.4. ensure that reports of Latvia would be the observed drug side effects CAI immediately, but not later than 15dien after receipt of the report would be available in the registration certificate holder (owner);
11.5. this rule 8.4. effects of medicinal products referred to in the analysis and monitoring, if Latvia is 8.4. those provisions referred to in the bottom of the reference Member State;
11.6. the European Parliament and of the Council of 31 March 2004, Regulation (EC) No 726/2004 of the Community procedures of medicinal products for human and veterinary use logging and monitoring and the European Medicines Agency said the national monitoring system of the responsibilities of the competent institution.
12. If after evaluation of the monitoring system data in the State Agency of medicines shall decide that the activities of the registration certificate of license should be suspended, to be cancelled or changes should be made in the registration dossier, in accordance with the recommendations of the European Commission, it shall immediately inform the European Medicines Agency, the competent institution of the other Member States and the registration certificate holder (owner).
13. If there is a need for urgent measures to ensure the protection of public health, State Agency of medicines has the right to suspend the operation of the registration certificate of the medicinal product, provided that it is not later than the next working day shall inform the European Medicines Agency, the European Commission and the competent authorities of the other Member States of the respective registration licence suspension and the measures to be taken.
14. If you received a request from the European Commission, based on the regulations on the registration of the medicinal product prescribed by the Standing Committee's views on products that are distributed in the territory of Latvia, the State Agency of medicines urgently take the necessary provisional measures and subsequent acts in accordance with the received opinion.
15. national pharmaceutical inspectorate and medical care and integrity inspection quality control inspection within their competence, control of compliance with these rules.
IV. final question 16. Be declared unenforceable in the Cabinet of Ministers of 6 March 2001, Regulation No 104 ' of pharmacovigilance rules "(Latvian journal, 2001, 39 no; 2003, 167 no).
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, Directive 2001/83/EC on the Community code relating to medicinal products for human use;
2) of the European Parliament and of the Council of 31 March 2004, Directive 2004/27/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Prime Minister a. Halloween Health Minister g. Smith Editorial Note: rules shall enter into force on 9 December 2005.
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