What changed between the plenary report and the adopted text

Added:(b) except for the data referred to in point (a), the application file is complete and satisfies all the requirements of this Directive;

Added:(c) specific conditions are included in the decision of the competent authorities of the Member States, in particular to ensure the safety of the medicinal product as well to ensure that the marketing authorisation holder notifies to the competent authorities of the Member States any incident relating to its use and takes appropriate action where necessary.

Added:2. The maintenance of the authorised new therapeutic indication and the validity of the national marketing authorisation shall be linked to the reassessment of the conditions set out in paragraph 1 after two years from the date when the new therapeutic indication was authorised or the marketing authorisation was granted, and thereafter at a risk-based frequency to be determined by the competent authorities of the Member State and specified in the marketing authorisation.

Added:This reassessment shall be conducted on the basis of an application by the marketing authorisation holder to maintain the authorised new therapeutic indication or renew the marketing authorisation under exceptional circumstances.

Added:Article 46 Validity and renewal of marketing authorisation

Added:1. Without prejudice to paragraph 4, a marketing authorisation for a medicinal product shall be valid for an unlimited period.

Added:By way of derogation from the first subparagraph, a national marketing authorisation granted in accordance with Article 45(1) shall be valid for five years and be subject to renewal in accordance with paragraph 2.

Added:By way of derogation from the first subparagraph, a competent authority of the Member State may decide at the time of granting the national marketing authorisation, on objectively and duly justified grounds relating to safety of the medicinal product, to limit the validity of the national marketing authorisation to five years.

Added:2. The marketing authorisation holder may submit an application for a renewal of a national marketing authorisation granted under paragraph 1, second or third subparagraph. Such application shall be submitted at least nine months before the national marketing authorisation ceases to be valid.

Added:3. Once the application for a renewal has been submitted within the time limit provided for in paragraph 2, the national marketing authorisation shall remain valid until the competent authority of the Member State adopts a decision.

Added:4. The competent authority of the Member State may renew the national marketing authorisation on the basis of a re-evaluation of the benefit-risk balance. Once renewed, the marketing authorisation shall be valid for an unlimited period.

Added:Article 47 Refusal of a national marketing authorisation

Added:1. The national marketing authorisation shall be refused if, after verification of the particulars and documentations referred to in Article 6 and subject to the specific requirements laid down in Articles 9 to 14, the view is taken that:

Added:(a) the benefit-risk balance is not considered to be favourable;

Added:(b) that the applicant has not properly or sufficiently demonstrated the quality, safety or efficacy of the medicinal product;

Added:(c) its qualitative and quantitative composition is not as declared;

Added:(d) the environmental risk assessment is incomplete or insufficiently substantiated, and the reason for the incomplete nature of the environmental risk assessment is not duly justified and substantiated by the applicant, or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant or by the risk mitigation measures included by the applicant, in accordance with Article 22(3); [Am. 158]

Added:(da) For medicinal products where the reference medicinal product received its first marketing authorisation before 30 October 2005, the national marketing authorisation may be refused if the view is taken that the environmental risk assessment is incomplete or insufficiently substantiated and those medicinal products can be identified as potentially harmful to the environment. [Am. 159]

Added:(e) the labelling and package leaflet proposed by the applicant are not in accordance with Chapter VI.

Added:2. The national marketing authorisation shall also be refused if any particulars or documentations submitted in support of the application do not comply with Article 6, paragraphs 1 to 6, and Articles 9 to 14.

Added:3. The applicant or the marketing authorisation holder shall be responsible for the accuracy of the particulars and documentations submitted.

Added:Section 7 Specific requirements for paediatric medicinal products

Added:Article 48 Compliance with the paediatric investigation plan

Added:1. The competent authority of the Member State for which an application for marketing authorisation or variation of a marketing authorisation is submitted under the provisions of this Chapter or of the Chapter VIII, shall verify whether it complies with the requirements laid down in Article 6(5).

Added:2. Where the application is submitted in accordance with the procedure set out in this Chapter, Sections 3 and 4, the verification of compliance, including, as appropriate, requesting an opinion of the Agency in accordance with paragraph 3, point (b), shall be conducted by the reference Member State.

Added:3. The Committee for Medicinal Products for Human Use, as referred to in Article 148 of [revised Regulation (EC) No 726/2004] may, in the following cases, be requested to give its opinion as to whether studies conducted by the applicant are in compliance with the agreed paediatric investigation plan as defined in Article 74 of [revised Regulation (EC) No 726/2004]:

Added:(a) by the applicant, prior to submitting an application for a marketing authorisation or for a variation of a marketing authorisation;

Added:(b) by the competent authority of the Member State, when validating an application for a marketing authorisation or for a variation of a marketing authorisation that does not already include such an opinion.

Added:4. In the case of a request in accordance with paragraph 3, point (a), the applicant shall not submit its application until the Committee for Medicinal Products for Human Use has provided its opinion, and a copy thereof shall be annexed to the application.

Added:5. Member States shall take due account of an opinion drawn up in accordance with paragraph 3.

Added:6. When the competent authority of the Member State, during the scientific assessment of a valid application for a marketing authorisation or a variation of a marketing authorisation, concludes that the studies are not in conformity with the agreed paediatric investigation plan, the medicinal product shall not be eligible for the rewards and incentives provided for in Article 86.

Added:Article 49 Data deriving from a paediatric investigation plan

Added:1. Where a marketing authorisation or a variation of a marketing authorisation, is granted in accordance with the provisions under this Chapter or of the provisions under Chapter VIII:

Added:(a) the results of all clinical studies, conducted in compliance with an agreed paediatric investigation plan as referred to in Article 6(5), point (a), shall be included in the summary of product characteristics and, if appropriate, in the package leaflet, or

Added:(b) any agreed waiver as referred to in Article 6(5), points (b) and (c), shall be recorded in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned.

Added:2. If the application complies with all the measures contained in the agreed completed paediatric investigation plan and if the summary of product characteristics reflects the results of studies conducted in compliance with that agreed paediatric investigation plan, the competent authority of the Member State shall include within the marketing authorisation a statement indicating compliance of the application with the agreed completed paediatric investigation plan. The competent authority shall make the conclusions of the assessment regarding compliance with the agreed completed paediatric investigation plan publicly available. [Am. 160]

Added:3. An application for new therapeutic indications, including paediatric indications, new pharmaceutical forms, new strengths and new routes of administration of medicinal products authorised in accordance with the provisions under this Chapter or of the provisions under Chapter VIII and which are protected either by a supplementary protection certificate under [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted], or by a patent which qualifies for the granting of the supplementary protection certificate, may be submitted under the procedure laid down in Articles 41 and 42.

Added:4. The procedure referred to in paragraph 3 shall be limited to the assessment of the specific section of the summary of product characteristics to be varied.

Added:Chapter IV Prescription status

Added:Article 50 Prescription status of medicinal products

Added:1. When a marketing authorisation is granted, the competent authorities shall, by applying the criteria laid down in Article 51, specify the prescription status of the medicinal product as:

Added:(a) a medicinal product subject to medical prescription; or

Added:(b) a medicinal product not subject to medical prescription.

Added:2. The competent authorities may fix sub-categories for medicinal products that are subject to medical prescription. In that case, they shall specify the following prescription status:

Added:(a) medicinal products subject to medical prescription for renewable or non-renewable delivery;

Added:(b) medicinal products subject to special medical prescription;

Added:(c) medicinal products on ‘restricted’ medical prescription, reserved for use in certain specialised areas.

Added:Article 51 Medicinal products subject to medical prescription

Added:1. A medicinal product shall be subject to medical prescription where it:

Added:(a) is likely to present a danger either directly or indirectly, even when used correctly, if used without medical supervision;

Added:(b) is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health;

Added:(c) contains substances or preparations thereof, the activity or adverse reactions of which require further investigation;

Added:(d) is normally prescribed by a doctor to be administered parenterally;

Added:(e) is an antibiotic or any other antimicrobial for which there is an identified risk of antimicrobial resistance; or [Am. 161]

Added:(f) contains an active substance, adjuvants or any other ingredients or constituent parts which are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise. [Am. 162]

Added:1a. The Commission shall adopt implementing acts to add further antimicrobial products that shall be subject to prescription status where the Agency has identified a risk of antimicrobial resistance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). [Am. 163]

Added:2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned by authorising the use of pre-cut blister units or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription. [Am. 164]

Added:2a. A prescription for antibiotic products shall be subject to the following conditions:

Added:(a) be limited to the amount required for the treatment or therapy concerned;

Added:(b) only be prescribed for a limited duration to cover the period of risk when used as prophylaxis;