Activities in pharmacovigilance regulations

 

 

This regulation is in line with the European Council Directive 75/319 EEC of 20 May 1975 and WHO

 


Chapter 1


Definitions and general principles


Article 1


Pharmacovigilance 1.Prin means all activities detection, evaluation, validation and prevention of adverse reactions to medicinal products.


2.Scopurile pharmacovigilance activities are:

early detection of adverse reactions and interactions of medicinal products;

monitoring frequency of known adverse reactions;

identification of risk factors and fundamental mechanisms of adverse reactions;

the quantitative estimation of risk factors;

analysis and dissemination of information necessary prescription and regulation of medicinal products;

rational and safe use of medicinal products;

assessing and communicating risk / benefit for all medicinal products on the market.


Article 2


1. Based on the present Regulations, the National Medicines Agency will organize a national pharmacovigilance system with a site called the National Pharmacovigilance Centre at the National Medicines Agency structure.


2. This system is used to collect useful information on supervision of medicinal products, with particular reference to adverse reactions in humans. National Pharmacovigilance Center of the National Medicines Agency assesses the scientific point of view this information.


3. This information must be correlated with data on consumption of medicinal products in the territory.


4. 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 field are defined as follows:


a)-reaction adverse reaction is harmful and unintended and which occurs at doses normally used in man for prophylaxis,

     diagnosis or treatment of disease or for modification of physiological functions;

b) - serious adverse reaction means an adverse reaction which:

   - Is fatal,

   - Endanger life

   - Requires hospitalization or prolongation of hospitalization person existing

   - Lead to disability / incapacity or persistent or significant congenital anomaly / birth defects.

c) - unexpected adverse reaction means an adverse reaction whose nature, severity and / or outcome does not correspond to information in

     SPC;

d) - serious and unexpected adverse reaction means an adverse reaction which cumulatively fulfills the provisions of subparagraphs b and c.


    Chapter 2


    Obligations of marketing authorization holder


Article 4


1. Marketing authorization holder of a medicinal product must always have at his disposal an appropriately qualified person responsible for pharmacovigilance.


2. The qualified person responsible for:


a) establishing and maintaining a system which ensures that information about all suspected adverse reactions which are reported to the company and to medical representatives, is collected in a single center;


b) preparing reports for National Pharmacovigilance Center of the National Medicines Agency, as established by the National Medicines Agency in accordance with national regulations and guidelines in force;


c) ensuring that any request from the National Pharmacovigilance Centre within the National Medicines Agency for the provision of additional information necessary to assess the benefits and potential risks of a medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions of the medicinal product .


Article 5


1. Marketing authorization holder of a medicinal product is required to record and report to the National Pharmacovigilance Center of the National Medicines Agency immediately or within 15 days of receipt of all suspected serious adverse reactions which are brought to its attention by medical personnel.


2.Detinatorul Marketing Authorization of medicinal product must keep detailed records of all suspected adverse reactions reported by health care professionals.


3. Documents must be submitted to the National Pharmacovigilance Center of the National Medicines Agency immediately upon request or six months during the first two years after marketing authorization, and once a year in the next three years. After that documents should be submitted at five-yearly intervals together with the application for renewal of the permit. These records must be accompanied by their scientific evaluation.


Chapter 3


Of the National Agency for Medicines


Article 6


1. National Medicines Agency will identify and apply appropriate measures to encourage doctors to report to the National Pharmacovigilance Centre suspected adverse reactions.


2.In certain cases, the National Medicines Agency may require medical monitoring and reporting primarily certain suspected serious or unexpected adverse reactions to certain drugs.


Article 7


National Medicines Agency will immediately or within 15 days to the attention of the European Agency for the Evaluation of Medicinal Products reports of suspected serious adverse reactions for products authorized through the centralized procedure or marketing authorization holder for the medicinal product authorized products nationally.


Article 8


1. For products authorized through the centralized procedure, if the evaluation of adverse reaction reports, the National Pharmacovigilance Center of the National Medicines Agency believes it is necessary to permit a variation, suspension or withdrawal, he should immediately inform the European Agency for the Evaluation medicinal products. For products authorized through national procedure, if the evaluation of adverse reaction reports, the National Pharmacovigilance Center of the National Medicines Agency believes it is necessary to permit a variation, suspension or withdrawal, he should immediately inform Authorization Holder medicinal product on the market.


2. In emergencies, the National Medicines Agency may block the distribution of the medicinal product is necessary for centrally authorized products to inform the European Agency for the Evaluation of Medicinal Products on this within 1 working day after the decision.


Article 9


For the implementation of these Regulations, the National Pharmacovigilance Center of the National Medicines Agency will comply with the collection, verification and presentation of adverse reaction reports. These rules are in accordance with existing guidelines in the EU area.

 

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