Pharmacovigilance
Regulations concerning pharmacovigilance activity
The present regulations are in accordance with the European Council Directive 75/319 EEC from May 20th, 1975 and WHO provisions.
Chapter 1
Definitions and general principles
Article 1
Pharmacovigilance means the total activity of detection, evaluation, validation and prevention of adverse reactions to medicinal products. The purposes of pharmacovigilance activity are: precocious detection of adverse reactions and medicinal products interactions; monitoring of known adverse reactions frequency; identification of risk factors and fundamental mechanisms of adverse reactions; estimation of quantitative aspects on risk factors; analysis and dissemination of necessary information for appropriate prescription and regulation of medicinal products circuit; rational and safe use of medicinal products; evaluation and communication of risks/benefits ratio of all medicinal products placed on the market.
Article 2
Based on the present Regulation, the National Medicines Agency will organize a National Pharmacovigilance System having a main site called National Pharmacovigilance Center within the National Medicines Agency’s structure. This system is used to collect useful information in the surveillance of medicinal products, with particular reference to adverse reactions in humans. The National Pharmacovigilance Center of the National Medicines Agency evaluates such information from scientifically point of view. Such information should be correlated with data on consumption of medicinal products into territory. This system should also collect and evaluate information on frequently observed misuse and serious abuse of medicinal products.
Article 3
The main terms used in this domain are defined as follow: adverse reaction means a reaction which is harmful and unintended and which occurs at doses normally used in humans for the prophylaxis, diagnosis or treatment of disease or the modification of physiological functions; serious adverse reaction means an adverse reaction which: is fatal, is life-threatening, results in or prolongs an existing inpatient hospitalization, results in a persistent or significant disability/incapacity or in a congenital anomaly/birth defect; unexpected adverse reaction means an adverse reaction of which nature, seriousness and/or result do not correspond to information of the summary of product characteristics; serious and unexpected adverse reaction means an adverse reaction, which fulfils provisions of both item b and c.
Chapter 2
Obligations of Marketing Authorization Holder
Article 4
The Marketing Authorization Holder should have permanently at his disposal an appropriately qualified person responsible for pharmacovigilance activity. This qualified person is responsible for the following: the establishment and maintenance of a system which ensure that information about all suspected adverse reactions which are reported to the personnel of the company, and to medical representatives, is collected at a single point center; the elaboration of the reports for the National Pharmacovigilance Center of the National Medicines Agency, in form established by National Medicines Agency, in accordance with the in force national regulations and guidelines; ensuring that any request from the National Pharmacovigilance Center of the National Medicines Agency for the provision of additional information necessary for the evaluation of the possible benefits and risks afforded by a medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions of the medicinal product concerned.
Article 5
The Marketing Authorization Holder of the medicinal product is obliged to record and to report all suspected serious adverse reactions which are brought to his attention by health care professionals to the National Pharmacovigilance Center of the National Medicines Agency immediately, or within 15 days of their receipt at the latest. The Marketing Authorization Holder of the medicinal product is obliged to keep detailed records of all suspected adverse reactions, which are reported to him by health care professionals. These records should be submitted to the National Pharmacovigilance Center of the National Medicines Agency immediately upon request or at least every six months during the first two years following marketing authorization, and once a year for the following three years. Thereafter, the records should be submitted at five-yearly intervals together with the application for renewal of the authorization. These records should be accompanied by their scientific evaluation.
Chapter 3
Attributions of National Medicines Agency
Article 6
The National Medicines Agency will identify and take all appropriate measures to encourage physicians to report suspected adverse reactions to the National Pharmacovigilance Center. In certain cases, the National Medicines Agency may request physicians to follow up and to report primarily certain suspected serious or unexpected adverse reactions for certain medicinal products.
Article 7
The National Medicines Agency will brought immediately or within 15 days at the latest, to the attention of the European Medicine Evaluation Agency the reports of suspected serious adverse reactions for products authorized by centralized procedure and to the attention of Marketing Authorization Holder for products authorized by national procedure.
Article 8
For products authorized through centralized procedure, where as a result of the evaluation of adverse reaction reports the National Pharmacovigilance Center of the National Medicines Agency considers that a marketing authorization should be varied, suspended or withdrawn, it should immediately inform the European Medicine Evaluation Agency. For products authorized by national procedure, if as a result of the evaluation of adverse reaction reports, the National Pharmacovigilance Center of the National Medicines Agency considers that a marketing authorization should be varied, suspended or withdrawn, it should immediately inform the Marketing Authorization Holder of the medicinal product.
In case of urgency, the National Medicines Agency may block the distribution of the medicinal product, being required that for the products authorized by centralized procedure to inform the European Medicine Evaluation Agency within 1 working day after the decision was given.
Article 9
To put into practice these Regulations, the National Pharmacovigilance Center of the National Medicines Agency will respect the norms regarding the collection, verification and presentation of adverse reaction reports. These norms are in accordance with the European Union guidelines in the field.
Chapter 1
Definitions and general principles
Article 1
Pharmacovigilance means the total activity of detection, evaluation, validation and prevention of adverse reactions to medicinal products. The purposes of pharmacovigilance activity are: precocious detection of adverse reactions and medicinal products interactions; monitoring of known adverse reactions frequency; identification of risk factors and fundamental mechanisms of adverse reactions; estimation of quantitative aspects on risk factors; analysis and dissemination of necessary information for appropriate prescription and regulation of medicinal products circuit; rational and safe use of medicinal products; evaluation and communication of risks/benefits ratio of all medicinal products placed on the market.
Article 2
Based on the present Regulation, the National Medicines Agency will organize a National Pharmacovigilance System having a main site called National Pharmacovigilance Center within the National Medicines Agency’s structure. This system is used to collect useful information in the surveillance of medicinal products, with particular reference to adverse reactions in humans. The National Pharmacovigilance Center of the National Medicines Agency evaluates such information from scientifically point of view. Such information should be correlated with data on consumption of medicinal products into territory. This system should also collect and evaluate information on frequently observed misuse and serious abuse of medicinal products.
Article 3
The main terms used in this domain are defined as follow: adverse reaction means a reaction which is harmful and unintended and which occurs at doses normally used in humans for the prophylaxis, diagnosis or treatment of disease or the modification of physiological functions; serious adverse reaction means an adverse reaction which: is fatal, is life-threatening, results in or prolongs an existing inpatient hospitalization, results in a persistent or significant disability/incapacity or in a congenital anomaly/birth defect; unexpected adverse reaction means an adverse reaction of which nature, seriousness and/or result do not correspond to information of the summary of product characteristics; serious and unexpected adverse reaction means an adverse reaction, which fulfils provisions of both item b and c.
Chapter 2
Obligations of Marketing Authorization Holder
Article 4
The Marketing Authorization Holder should have permanently at his disposal an appropriately qualified person responsible for pharmacovigilance activity. This qualified person is responsible for the following: the establishment and maintenance of a system which ensure that information about all suspected adverse reactions which are reported to the personnel of the company, and to medical representatives, is collected at a single point center; the elaboration of the reports for the National Pharmacovigilance Center of the National Medicines Agency, in form established by National Medicines Agency, in accordance with the in force national regulations and guidelines; ensuring that any request from the National Pharmacovigilance Center of the National Medicines Agency for the provision of additional information necessary for the evaluation of the possible benefits and risks afforded by a medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions of the medicinal product concerned.
Article 5
The Marketing Authorization Holder of the medicinal product is obliged to record and to report all suspected serious adverse reactions which are brought to his attention by health care professionals to the National Pharmacovigilance Center of the National Medicines Agency immediately, or within 15 days of their receipt at the latest. The Marketing Authorization Holder of the medicinal product is obliged to keep detailed records of all suspected adverse reactions, which are reported to him by health care professionals. These records should be submitted to the National Pharmacovigilance Center of the National Medicines Agency immediately upon request or at least every six months during the first two years following marketing authorization, and once a year for the following three years. Thereafter, the records should be submitted at five-yearly intervals together with the application for renewal of the authorization. These records should be accompanied by their scientific evaluation.
Chapter 3
Attributions of National Medicines Agency
Article 6
The National Medicines Agency will identify and take all appropriate measures to encourage physicians to report suspected adverse reactions to the National Pharmacovigilance Center. In certain cases, the National Medicines Agency may request physicians to follow up and to report primarily certain suspected serious or unexpected adverse reactions for certain medicinal products.
Article 7
The National Medicines Agency will brought immediately or within 15 days at the latest, to the attention of the European Medicine Evaluation Agency the reports of suspected serious adverse reactions for products authorized by centralized procedure and to the attention of Marketing Authorization Holder for products authorized by national procedure.
Article 8
For products authorized through centralized procedure, where as a result of the evaluation of adverse reaction reports the National Pharmacovigilance Center of the National Medicines Agency considers that a marketing authorization should be varied, suspended or withdrawn, it should immediately inform the European Medicine Evaluation Agency. For products authorized by national procedure, if as a result of the evaluation of adverse reaction reports, the National Pharmacovigilance Center of the National Medicines Agency considers that a marketing authorization should be varied, suspended or withdrawn, it should immediately inform the Marketing Authorization Holder of the medicinal product.
In case of urgency, the National Medicines Agency may block the distribution of the medicinal product, being required that for the products authorized by centralized procedure to inform the European Medicine Evaluation Agency within 1 working day after the decision was given.
Article 9
To put into practice these Regulations, the National Pharmacovigilance Center of the National Medicines Agency will respect the norms regarding the collection, verification and presentation of adverse reaction reports. These norms are in accordance with the European Union guidelines in the field.
