What changed between the plenary report and the adopted text

Added:(c) in the event that a diagnostic test has not been performed, a justification shall be required. [Am. 165]

Added:2b. Member States shall, wherever possible, provide per unit prescription and dispensing for the treatment or therapy concerned. [Am. 166]

Added:3. Where Member States provide for the sub-category of medicinal products subject to special medical prescription, they shall take account of the following factors:

Added:(a) the medicinal product contains, in a non-exempt quantity, a substance classified as a narcotic or a psychotropic substance within the meaning of the international conventions;

Added:(b) the medicinal product is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes; or

Added:(c) the medicinal product contains a substance that, by reason of its novelty or properties, could be considered as belonging to the group set out in point (a) as a precautionary measure.

Added:4. Where Member States provide for the sub-category of medicinal products subject to restricted prescription, they shall take account of the following factors:

Added:(a) the medicinal product, because of its pharmaceutical characteristics or novelty or in the interests of public health, is reserved for treatments that can only be followed in a hospital environment;

Added:(b) the medicinal product is used in the treatment of conditions that must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, although administration and follow-up may be carried out elsewhere;

Added:(c) the medicinal product is intended for outpatients but its use may produce very serious adverse reactions requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment.

Added:(ca) the risk of antimicrobial resistance, including any mitigating measures in that regard, from use of the medicinal product. [Am. 167]

Added:5. A competent authority may waive application of the paragraphs 1, 3 and 4 having regard to:

Added:(a) the maximum single dose, the maximum daily dose, the strength, the pharmaceutical form, certain types of packaging; or

Added:(b) other circumstances of use that it has specified. [Am. 168]

Added:6. If a competent authority does not designate medicinal products into sub-categories referred to in Article 50(2), it shall nevertheless take into account the criteria laid down in paragraphs 3 and 4 in determining whether any medicinal product shall be classified as a medicinal product subject to medical prescription.

Added:Article 52 Medicinal products not subject to medical prescription

Added:Medicinal products not subject to medical prescription shall be those that do not meet the criteria laid down in Article 51.

Added:Article 53 List of medicinal products subject to medical prescription

Added:The competent authorities shall draw up a list of the medicinal products subject, on their territory, to medical prescription, specifying, if necessary, the category of prescription status. They shall update this list annually.

Added:Article 54 Amendment of prescription status

Added:When new facts are brought to their attention, the competent authorities shall examine and, as appropriate, amend the prescription status of a medicinal product by applying the criteria listed in Article 51.

Added:Article 55 Data protection of evidence for the change of prescription status

Added:Where a change of prescription status of a medicinal product has been authorised on the basis of significant non-clinical tests or clinical studies, the competent authority shall not refer to the results of those tests or studies when examining an application by another applicant for or marketing authorisation holder for a change of prescription status of the same substance for one year after the initial change was authorised.

Added:Chapter V Obligations and liability of the marketing authorisation holder

Added:Article 56 General obligations

Added:1. The marketing authorisation holder shall be responsible for the making available on the market of the medicinal product covered by the marketing authorisation it has been granted. The designation of a marketing authorisation holder representative shall not relieve the marketing authorisation holder of its legal responsibility.

Added:2. The marketing authorisation holder of a medicinal product placed on the market in a Member State shall notify the competent authority of the Member State concerned of the date of actual placing on the market of the medicinal product in that Member State, taking into account the various presentations authorised.

Added:3. The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Added:The arrangements for implementing the first subparagraph should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of such protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.

Added:4. The marketing authorisation holder shall, at all stages of manufacturing and distribution ensure that the starting materials and ingredients of the medicinal products and the medicinal products themselves comply with the requirements of this Directive and, where relevant, the [revised Regulation (EC) No 726/2004] and other Union law and shall verify that such requirements are met.

Added:5. For integral combination of a medicinal product with a medical device and for combinations of a medicinal product with a product other than a medical device, the marketing authorisation holder shall be responsible for the whole product in terms of compliance of the medicinal product with the requirements of this Directive and the [revised Regulation (EC) No 726/2004].

Added:6. The marketing authorisation holder shall be established in the Union.

Added:7. Where the marketing authorisation holder considers or has reason to believe that the medicinal product it has made available on the market is not in conformity with the marketing authorisation or this Directive and the [revised Regulation (EC) No 726/2004] it shall immediately take the necessary corrective actions to bring that medicinal product into conformity, to withdraw it or recall it, as appropriate. The marketing authorisation holder shall immediately inform the competent authorities and the distributors concerned to that effect.

Added:8. Upon request, the marketing authorisation holder shall provide the competent authorities with free samples in sufficient quantities to enable controls to be made on the medicinal products that it has placed on the market.

Added:9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product, and any data in its possession relating to the volume of prescriptions.

Added:Article 57 Responsibility to report on public financial support

Added:1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority, publicly funded body or philanthropic or not-for-profit organisation or fund, irrespective of its geographic location, and any indirect financial support received from any public authority or publicly funded body, of the Union or its Member States in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support. [Am. 169]

Added:2. Within 30 days after the marketing authorisation is granted the marketing authorisation holder shall:

Added:(a) draw up an electronic report listing:

Added:(i) the amount of financial support received and the date thereof;

Added:(ii) the public authority or publicly funded bodyentity that provided the financial support referred to in point (i); [Am. 170]

Added:(iii) the legal entity that received the support referred to in point (i).

Added:(iiia) where relevant, any independent legal entity from which it obtained a licence in relation to, or acquired the medicinal product in its previous phases of development, and at which stage of the research and development process. The marketing authorisation holder shall, to the extent possible, include in the report information on funding received as referred to paragraph 1 specific to the relevant medicinal product. [Am. 171]

Added:(b) ensure that the electronic report is accurate and that it has been audited by an independent external auditor;

Added:(c) make the electronic report accessible to the public via a dedicated webpage;

Added:(d) communicate the electronic link to such webpage to the competent authority of the Member State or, where appropriate, to the Agency.

Added:3. For the medicinal products authorised under this Directive, the competent authority of the Member State shall communicate in a timely manner the electronic link to the Agency.

Added:4. The marketing authorisation holder shall keep the electronic link up to date and, as necessary, update the report annually.

Added:5. The Member States shall take appropriate measures to ensure that paragraphs 1, 2 and 4 are complied with by the marketing authorisation holder established in their country.

Added:6. The Commission mayshall adopt implementing acts to lay down the principles and format for the information to be reported pursuant to paragraph 2, by [12 months from the date of entry into force of this Directive]. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). [Am. 172]

Added:6a. The Agency shall provide on its website the links to the information communicated to the Agency in accordance with paragraphs 2 and 3, sorted, where relevant, by medicinal product and by Member State. [Am. 173]

Added:Article 58 Traceability of substances used in the manufacture of medicinal products

Added:1. The marketing authorisation holder shall, when necessary, ensure the traceability of an active substance, starting material, excipient or any other substance intended or expected to be present in a medicinal product at all stages of manufacturing and distribution.

Added:2. The marketing authorisation holder shall be able to identify any natural or legal person from whom they have been supplied with an active substance, starting material, excipient or any other substance intended or expected to be present in a medicinal product.

Added:3. The marketing authorisation holder and its suppliers of an active substance, starting material, excipient or any other substance used in the manufacturing of a medicinal product shall have in place systems and procedures that allow for the information referred to in paragraph 2 to be made available, upon request, to the competent authorities.

Added:4. The marketing authorisation holder and its suppliers shall have in place systems and procedures to identify the other natural or legal persons to whom products referred to in paragraph 2 have been supplied. This information shall, upon request, be made available to the competent authorities.

Added:Article 58a Obligation to submit an application for pricing and reimbursement in all Member States

Added:1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, in good faith and within the limits of its responsibilities, submit an application for pricing and reimbursement for the medicinal product and, where relevant, negotiate. In the case of a positive decision to permit the marketing of the medicinal product in accordance with Directive 89/105/EEC, the obligation in Article 56(3) of this Directive to ensure appropriate and continued supply to cover the needs of patients in that Member State shall apply. The application for pricing and reimbursement for the medicinal product shall be submitted no later than 12 months from the date when the Member State made its request, or within 24 months from that date for any of the following entities:

Added:(i) SMEs;

Added:(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and