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Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance) Article 122

Article 122

1. Member States shall take all appropriate measures to ensure that the competent authorities concerned communicate to each other such information as is appropriate to guarantee that the requirements placed on the authorisations referred to in Articles 40 and 77, on the certificates referred to in Article 111(5) or on the marketing authorisations are fulfilled. 2. Upon reasoned request, Member States shall forthwith communicate the reports referred to in Article 111(3) to the competent authorities of another Member State. 3. The conclusions reached in accordance with Article 111(1) shall be valid throughout the Community. However, in exceptional cases, if a Member State is unable, for reasons relating to public health, to accept the conclusions reached following an inspection under Article 111(1), that Member State shall forthwith inform the Commission and the Agency. The Agency shall inform the Member States concerned. When the Commission is informed of these divergences of opinion, it may, after consulting the Member States concerned, ask the inspector who performed the original inspection to perform a new inspection; the inspector may be accompanied by two other inspectors from Member States which are not parties to the disagreement."; 83) in Article 125, the third subparagraph shall be replaced by the following:"Decisions to grant or revoke a marketing authorisation shall be made publicly available."; 84) the following Article shall be inserted: "Article 126a 1. In the absence of a marketing authorisation or of a pending application for a medicinal product authorised in another Member State in accordance with this Directive, a Member State may for justified public health reasons authorise the placing on the market of the said medicinal product. 2. When a Member State avails itself of this possibility, it shall adopt the necessary measures in order to ensure that the requirements of this Directive are complied with, in particular those referred to in Titles V, VI, VIII, IX and XI. 3. Before granting such an authorisation a Member State shall: (a) notify the marketing authorisation holder, in the Member State in which the medicinal product concerned is authorised, of the proposal to grant an authorisation under this Article in respect of the product concerned; and (b) request the competent authority in that State to furnish a copy of the assessment report referred to in Article 21(4) and of the marketing authorisation in force in respect of the said medicinal product. 4. The Commission shall set up a publicly accessible register of medicinal products authorised under paragraph 1. Member States shall notify the Commission if any medicinal product is authorised, or ceases to be authorised, under paragraph 1, including the name or corporate name and permanent address of the authorisation holder. The Commission shall amend the register of medicinal products accordingly and make this register available on their website. 5. No later than 30 April 2008, the Commission shall present a report to the European Parliament and the Council concerning the application of this provision with a view to proposing any necessary amendments."; 85) the following Article 126b is inserted: "Article 126b In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry which could affect their impartiality. These persons shall make an annual declaration of their financial interests. In addition, the Member States shall ensure that the competent authority makes publicly accessible its rules of procedure and those of its committees, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions."; 86) the following Article shall be inserted: "Article 127a When a medicinal product is to be authorised in accordance with Regulation (EC) No 726/2004 and the Scientific Committee in its opinion refers to recommended conditions or restrictions with regard to the safe and effective use of the medicinal product as provided for in Article 9(4)(c) of that Regulation, a decision addressed to the Member States shall be adopted in accordance with the procedure provided for in Articles 33 and 34 of this Directive, for the implementation of those conditions or restrictions."; 87) the following Article shall be inserted: "Article 127b Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired."

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