Article 88a
Within three years of the entry into force of Directive 2004/726/EC, the Commission shall, following consultations with patients' and consumers' organisations, doctors' and pharmacists' organisations, Member States and other interested parties, present to the European Parliament and the Council a report on current practice with regard to information provision - particularly on the Internet - and its risks and benefits for patients. Following analysis of the above data, the Commission shall, if appropriate, put forward proposals setting out an information strategy to ensure good-quality, objective, reliable and non-promotional information on medicinal products and other treatments and shall address the question of the information source's liability."; 64) Article 89 shall be amended as follows: (a) the first indent of point (b) of paragraph 1 shall be replaced by the following: (does not affect the English version); (b) paragraph 2 shall be replaced by the following: "2. Member States may decide that the advertising of a medicinal product to the general public may, notwithstanding paragraph 1, include only the name of the medicinal product or its international non-proprietary name, where this exists, or the trademark if it is intended solely as a reminder."; 65) in Article 90, point (l) shall be deleted; 66) in Article 91, paragraph 2 shall be replaced by the following: "2. Member States may decide that the advertising of a medicinal product to persons qualified to prescribe or supply such products may, notwithstanding paragraph 1, include only the name of the medicinal product, or its international non-proprietary name, where this exists, or the trademark, if it is intended solely as a reminder."; 67) Article 94(2) shall be replaced by the following: "2. Hospitality at sales promotion events shall always be strictly limited to their main purpose and must not be extended to persons other than health-care professionals."; 68) Article 95 shall be replaced by the following: "Article 95 The provisions of Article 94(1) shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes; such hospitality shall always be strictly limited to the main scientific objective of the event; it must not be extended to persons other than health-care professionals."; 69) point (d) of Article 96(1) shall be replaced by the following: "(d) each sample shall be no larger than the smallest presentation on the market;"; 70) in Article 98, the following paragraph shall be added: "3. The Member States shall not prohibit the co-promotion of a medicinal product by the holder of the marketing authorisation and one or more companies nominated by him."; 71) Article 100 shall be replaced by the following: "Article 100 Advertising of the homeopathic medicinal products referred to in Article 14(1) shall be subject to the provisions of this Title with the exception of Article 87(1). However, only the information specified in Article 69(1) may be used in the advertising of such medicinal products."; 72) in Article 101, the second paragraph shall be replaced by the following:"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."; 73) Article 102 shall be replaced by the following: "Article 102 In order to ensure the adoption of appropriate and harmonised regulatory decisions concerning the medicinal products authorised within the Community, having regard to information obtained about adverse reactions to medicinal products under normal conditions of use, the Member States shall operate 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. Member States shall ensure that suitable information collected within this system is communicated to the other Member States and the Agency. The information shall be recorded in the database referred to in point (l) of the second subparagraph of Article 57(1) of Regulation (EC) No 726/2004 and shall be permanently accessible to all Member States and without delay to the public. 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."; 74) the following Article shall be inserted: "Article 102a The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities in order to guarantee their independence."; 75) in Article 103, the introductory phrase of the second paragraph shall be replaced by the following: "That qualified person shall reside in the Community and shall be responsible for the following:"; 76) Articles 104 to 107 shall be replaced by the following: "Article 104 1. The marketing authorisation holder shall be required to maintain detailed records of all suspected adverse reactions occurring either in the Community or in a third country. Save in exceptional circumstances, these reactions shall be communicated electronically in the form of a report in accordance with the guidelines referred to in Article 106(1). 2. The marketing authorisation holder shall be required to record all suspected serious adverse reactions which are brought to his attention by a health-care professional and to report them promptly to the competent authority of the Member State on whose territory the incident occurred, and no later than 15 days following the receipt of the information. 3. The marketing authorisation holder shall be required to record and report all other suspected serious adverse reactions which meet the notification criteria in accordance with the guidelines referred to in Article 106(1), of which he can reasonably be expected to have knowledge, promptly to the competent authority of the Member State in whose territory the incident occurred, and no later than 15 days following the receipt of the information. 4. The marketing authorisation holder shall ensure that all suspected serious unexpected adverse reactions and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country are reported promptly in accordance with the guidelines referred to in Article 106(1), so that the Agency and the competent authorities of the Member States in which the medicinal product is authorised are informed of them, and no later than 15 days following the receipt of the information. 5. By way of derogation from paragraphs 2, 3 and 4, in the case of medicinal products which are covered by Directive 87/22/EEC or which have qualified for the procedures laid down in Articles 28 and 29 of this Directive or which have been the subject of the procedures under Articles 32, 33 and 34 of this Directive, the marketing authorisation holder shall also ensure that all suspected serious adverse reactions occurring in the Community are reported in such a way as to be accessible to the reference Member State or to any competent authority acting as reference Member State. The reference Member State shall assume the responsibility of analysing and monitoring such adverse reactions. 6. Unless other requirements have been laid down as a condition for the granting of the marketing authorisation, or subsequently as indicated in the guidelines referred to in Article 106(1), reports of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, immediately upon request or at least every six months after authorisation and until the placing on the market. Periodic safety update reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market and once a year for the following two years. Thereafter, the reports shall be submitted at three-yearly intervals, or immediately upon request. The periodic safety update reports shall include a scientific evaluation of the risk-benefit balance of the medicinal product. 7. The Commission may lay down provisions to amend paragraph 6 in view of experience gained through its operation. The Commission shall adopt the provisions in accordance with the procedure referred to in Article 121(2). 8. Following the granting of a marketing authorisation, the marketing authorisation holder may request the amendment of the periods referred to in paragraph 6 in accordance with the procedure laid down by Commission Regulation (EC) No 1084/2003(14). 9. The holder of a marketing authorisation may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised medicinal product without giving prior or simultaneous notification to the competent authority. In any case, the marketing authorisation holder shall ensure that such information is presented objectively and is not misleading. Member States shall take the necessary measures to ensure that a marketing authorisation holder who fails to discharge these obligations is subject to effective, proportionate and dissuasive penalties.