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The Member States shall take all appropriate measures to encourage doctors and other health care professionals to report suspected adverse reactions to the competent authorities. The Member States may impose specific requirements on doctors and other health care professionals, in respect of the reporting of suspected serious or unexpected adverse reactions, in particular where such reporting is a condition of the marketing authorization.
In order to ensure the adoption of appropriate regulatory decisions concerning the medicinal products authorized within the Community, having regard to information obtained about adverse reactions to medicinal products under normal conditions of use, the Member States shall establish a pharmacovigilance system. This system shall be used to collect information useful in the surveillance of medicinal products, with particular reference to adverse reactions in human beings, and to evaluate such information scientifically. Such information shall be collated with data on consumption of medicinal products. This system shall also take into account any available information on misuse and abuse of medicinal products which may have an impact on the evaluation of their benefits and risks.
The marketing authorization holder shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance. That qualified person shall be responsible for the following: (a) the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the company, and to medical representatives, is collected and collated in order to be accessible at least at one point within the Community; (b) the preparation for the competent authorities of the reports referred to in Article 104, in such form as may be laid down by those authorities, in accordance with the guidance referred to in Article 106(1); (c) ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the 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; (d) the provision to the competent authorities, of any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on post-authorization safety studies.
1. The marketing authorization holder shall be required to maintain detailed records of all suspected adverse reactions occurring either in the Community or in a third country. 2. The marketing authorization holder shall be required to record and to report all suspected serious adverse reactions which are brought to his attention by a health care professional immediately to the competent authority of the Member State in whose territory the incident occurred, and in no case later than 15 calendar days following the receipt of the information. 3. The marketing authorization holder shall be required to record and report all other suspected serious adverse reactions which meet the reporting criteria in accordance with the guidance referred to in Article 106(1) of which he can reasonably be expected to have knowledge immediately to the competent authority of the Member State in whose territory the incident occurred, and in no case later than 15 calendar days following the receipt of the information. 4. The marketing authorization holder shall ensure that all suspected serious and unexpected adverse reactions occurring in the territory of a third country and brought to his attention by a health care professional are reported immediately in accordance with the guidance referred to in Article 106(1), so that they are available to the Agency and to the competent authorities of the Member States where the medicinal product is authorised, and in no case later than 15 calendar days following the receipt of the information. 5. In the case of medicinal products which have been considered within the scope of Directive 87/22/EEC, or which have benefited from the procedures of mutual recognition foreseen in Articles 17 and 18 of this Directive, Article 28(4) of this Directive, and medicinal products for which there has been a referral to the procedures foreseen by Articles 32, 33 and 34 of this Directive, the marketing authorisation holder shall additionally ensure that all suspected serious adverse reactions occurring in the Community are reported in the format and at intervals to be agreed with the reference Member State, or a competent authority acting as the reference Member State, in such a way so as to be accessible to the reference Member State. 6. Unless other requirements have been laid down as a condition of the granting of authorisation, or subsequently as indicated in the guidance referred to in Article 106(1), records of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, either immediately upon request or periodically as follows: six monthly for the first two years after authorisation, annually for the subsequent two years, and at the time of the first renewal. Thereafter the periodic safety update reports shall be submitted at five-yearly intervals together with the application for renewal of the authorisation. The periodic safety update reports shall include a scientific evaluation of the benefit and risks afforded by the medicinal products. 7. Following the granting of a marketing authorisation, the marketing authorisation holder may request the amendment of the periods referred to in this article according to the procedure laid down by Commission Regulation (EC) No 541/95(23).
1. The Agency, in collaboration with the Member States and the Commission shall set up a data-processing network to facilitate the exchange of pharmacovigilance information regarding medicinal products marketed in the Community intended to allow all competent authorities to share the information at the same time. 2. Making use of the network foreseen in paragraph 1, Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the Agency and the other Member States, and in any case within 15 calendar days of their notification, at the latest. 3. The Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the marketing authorisation holder, and in any case within 15 calendar days of their notification, at the latest.
1. In order to facilitate the exchange of information about pharmacovigilance within the Community, the Commission, in consultation with the Agency, Member States and interested parties, shall draw up guidance on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of pharmacovigilance information in accordance with internationally agreed formats and shall publish a reference to an internationally agreed medical terminology. This guidance shall be published in Volume 9 of The rules governing medicinal products in the European Community and shall take account of international harmonisation work carried out in the field of pharmacovigilance. 2. For the interpretation of the definitions referred to in Article 1 points 11 to 16 and the principles outlined in this Title, the marketing authorisation holder and the competent authorities shall refer to the guidance referred to in paragraph 1.
1. Where, as a result of the evaluation of pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied in accordance with the guidance referred to in Article 106(1), it shall forthwith inform the Agency, the other Member States and the marketing authorisation holder. 2. In case of urgency, the Member State concerned may suspend the marketing authorisation of a medicinal product, provided the Agency, the Commission and the other Member States are informed at the latest on the following working day.
Any amendments which may be necessary to update provisions of Articles 101 to 107 to take account of scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 121(2). TITLE X SPECIAL PROVISIONS ON MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD AND PLASMA
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