What changed between the plenary report and the adopted text

Added:(a) the rules governing the content and format of the application for an additional platform technology master file certificate;

Added:(b) additional platform technology master files for which a certificate may be used in order to provide specific information on the platform technology on the basis of which a substance present or used in the manufacturing of a medicinal product is manufactured;

Added:(c) the rules for the examination of applications for making publicly available of additional platform technology master file certificates;

Added:(d) the rules for introducing changes to the additional platform technology master file and the certificate;

Added:(e) the rules on access for competent authorities of the Member State to the additional platform technology master file and its assessment report;

Added:(f) the rules on access for marketing authorisation applicants and marketing authorisation holders relying on an additional platform technology master file certificate to the additional platform technology master file and to the assessment report.

Added:5. The Agency shall develop and publish scientific guidelines on the requirements for an additional platform technology master file.

Added:6. If requested by the Agency, the manufacturer of a substance present or used in the manufacturing of a medicinal product for which an application for an additional platform technology master file certificate has been submitted or the additional platform technology master file certificate holder shall undergo an inspection to verify the information contained in the application or the master file.

Added:If the holder of the additional platform technology master file refuses to undergo such an inspection, the Agency may suspend or terminate the application for the additional platform technology master file certificate. [Am. 143]

Added:Article 27 Excipients

Added:1. The applicant shall provide information on the excipients used in a medicinal product in accordance with the requirements set out in Annex II.

Added:Excipients shall be examined by the competent authorities as part of the medicinal product.

Added:2. Colours shall be used in medicinal products only if they are included in one of the following lists:

Added:(a) the Union list of authorised food additives in Table 1 in Part B of Annex II to Regulation (EC) No 1333/2008 and comply with the purity criteria and specifications laid down in Commission Regulation (EU) No 231/2012;

Added:(b) the list established by the Commission pursuant to paragraph 3.

Added:3. The Commission may establish a list of colours permitted for use in medicinal products other than those included in the Union list of authorised food additives.

Added:The Commission shall, where applicable on the basis of an opinion of the Agency, adopt a decision whether the colour concerned shall be added to list of colours permitted for use in medicinal products referred to in the first subparagraph.

Added:A colour may be added to the list of colours permitted for use in medicinal products only where the colour has been removed from the Union list of authorised food additives.

Added:Where relevant, the list of colours permitted for use in medicinal products shall include purity criteria, specifications or restrictions applicable to the colours included in that list.

Added:The list of colours permitted for use in medicinal products shall be established by way of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

Added:4. If a colour used in medicinal product is removed from the Union list of authorised food additives, on the basis of the scientific opinion of the European Food Safety Authority (‘EFSA’), the Agency shall, on the request of the Commission or on its own initiative, without undue delay issue a scientific opinion as regards the use of the colour concerned in medicinal product, taking into account the opinion of the EFSA if relevant. The opinion of the Agency shall be adopted by the Committee for Medicinal Products for Human Use. [Am. 144]

Added:The Agency without undue delay shall send to the Commission its scientific opinion on the use of the colour in medicinal product together with a report on the assessment.

Added:The Commission shall, on the basis of the Agency opinion, and without undue delay, decide whether the colour concerned can be used in medicinal products and, where applicable, include it in the list of colours permitted for use in medicinal products referred to in paragraph 3.

Added:5. If a colour has been removed from the Union list of authorised food additives for reasons that do not require an EFSA opinion, the Commission shall decide on the use of the colour concerned in medicinal products and, where applicable, include it in the list of colours permitted for use in medicinal products referred to in paragraph 3. The Commission mayshall, in such cases, request the opinion from the Agency. [Am. 145]

Added:6. A colour that has been removed from the Union list of authorised food additives can still be used as a colour in medicinal products until the Commission takes the decision on whether to include the colour on the list of colours permitted for use in medicinal products in accordance with paragraph 3.

Added:7. Paragraphs 2 to 6 shall also apply to colours used in veterinary medicinal products as defined in Article 4(1) of Regulation (EU) 2019/6 of the European Parliament and of the Council .

Added:Section 5 Adapted dossier requirements

Added:Article 28 Adapted frameworks due to the characteristics or methods inherent to the medicinal product

Added:1. Medicinal products listed in Annex VII shall be subject to specific scientific or regulatory requirements due to the characteristics or methods inherent to the medicinal product, when:

Added:(a) it is not possible to adequately assess the medicinal product or category of medicinal products applying the applicable requirements due to scientific or regulatory challenges arising from characteristics or methods inherent to the medicinal product; and

Added:(b) the characteristics or methods positively impact the quality, safety and efficacy of the medicinal product or category of medicinal product or provide a major contribution to patient access or patient care.

Added:2. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend Annex VII in order to take account of scientific and technical progress.

Added:3. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by laying down:

Added:(a) detailed rules for the marketing authorisation and supervision of the medicinal products referred to in paragraph 1;

Added:(b) the technical documentation to be submitted by applicants for marketing authorisations for medicinal products referred to in paragraph 1.

Added:4. The detailed rules referred to in paragraph 3, point (a), shall be proportionate to the risk and impact involved. These may entail adapted, enhanced, waived or deferred requirements. Any waiver or deferral shall be limited to the extent strictly necessary, proportionate and duly justified by the characteristics or methods inherent to the medicinal product, and shall be regularly reviewed and evaluated. Apart from the detailed rules referred to in paragraph 3, point (a), all other rules laid out in this Directive shall apply.

Added:5. Until the adoption of detailed rules for specific medicinal products listed in Annex VII pursuant to paragraph 3, an application for a marketing authorisation for that medicinal product may be submitted in accordance with Article 6(2).

Added:6. When adopting delegated acts referred to in this Article, the Commission shall take into account any available information resulting from a regulatory sandbox established in accordance with Article 115 of the [revised Regulation (EC) No 726/2004].

Added:6a. The Commission shall submit a report on the application of adapted frameworks to the European Parliament and to the Council. The first report shall be submitted five years from [OP please insert the date =18 months from the date of entry into force of this Directive] and then every five years thereafter. [Am. 146]

Added:Chapter III Procedures for national marketing authorisations

Added:Section 1 General provisions

Added:Article 29 Examination of marketing authorisation application

Added:1. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authority of the Member State:

Added:(a) shall verify whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;

Added:(b) may submit the medicinal product, its starting materials or ingredients and, if need be, its intermediate products or other, for testing by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose in order to ensure that the control methods employed by the manufacturer of medicinal products and described in the particulars accompanying the application in accordance with Annex I are satisfactory;

Added:(c) may, where appropriate, require the applicant to supplement the particulars accompanying the application in respect of the items listed in the Articles 6 and 9 to 14;

Added:(d) may consider and decide upon additional evidence available, independently from the data submitted by the marketing authorisation applicant.

Added:2. Where the competent authority of the Member State avails itself of the option referred to in the first subparagraph, point (c), the time limits laid down in Article 30 shall be suspended until such time as the supplementary information required has been provided or for the time allowed to the applicant for giving oral or written explanations.

Added:3. Where the competent authority of the Member State considers that the marketing authorisation application is incomplete, or contains critical deficiencies that may prevent the evaluation of the medicinal product it shall inform the applicant accordingly and shall set a time limit for submitting the missing information and documentation. If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn by default. [Am. 147]

Added:4. In cases where on examination of an application for a marketing authorisation the competent authority of the Member State considers that the submitted data are not of sufficient quality or maturity for the completion of the examination of the application, the examination can be terminated within 90 days of the validation of the application.

Added:The competent authority of the Member State shall summarise the deficiencies in writing. On this basis, the competent authority of the Member State shall inform the applicant accordingly and set a reasonable time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the Member State, the application shall be considered as withdrawn by default. [Am. 148]

Added:4a. When making public the information on the ERA and the antimicrobial stewardship and access plan referred to in Article 17, the competent authority shall delete any information of a commercially confidential nature. [Am. 149]

Added:Article 30 Duration of examination of marketing authorisation application

Added:Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 180 days after the submission of a valid application from the date of validation of a marketing authorisation application.

Added:Article 31 Types of national marketing authorisation procedures

Added:National marketing authorisations may be granted in accordance with the procedures laid down in Article 32 (‘purely national marketing authorisation procedure’), Articles 33 and 34 (‘decentralised procedure for national marketing authorisation’) or Articles 35 and 36 (‘mutual recognition procedure for national marketing authorisation’).

Added:Section 2 Marketing authorisations valid in a single Member State

Added:Article 32 Purely national marketing authorisation procedure

Added:1. An application for marketing authorisation according to Article 6(2) under the purely national marketing authorisation procedure shall be submitted to the competent authority in that Member State in which the marketing authorisation is applied.

Added:2. The competent authority in the Member State concerned shall examine the application in accordance with Articles 29 and 30 and grant a marketing authorisation in accordance with Articles 43 to 45 and applicable national provisions.