Changes from plenary report to adopted text

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

Added(e) the controls on the medicinal product or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the manufacturing authorisation has not been fulfilled; or

Added(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder.

Added(fa) commercial reasons. [Am. 130]

AddedWhere the action referred to in the first subparagraph is to withdraw a medicinal product from the market, the marketing authorisation holder shall provide information on the impact of such withdrawal on patients who are already being treated.

AddedThe notification of the permanent withdrawal of a medicinal product from the market or of the temporary suspension of the marketing authorisation, or of the permanent withdrawal of a marketing authorisation or of the temporary disruption in supply of a medicinal product shall be made in accordance with Article 116(1).

Added2. The marketing authorisation holder shall make the notification pursuant to paragraph 1 if the action is taken in a third country and such action is based on any of the grounds set out in Articles 195 or 196(1) of [revised Directive 2001/83/EC].

Added3. In the cases referred to in paragraphs 1 and 2, the Agency shall forward the information to the competent authorities of the Member States without undue delay.

Added3a. In the cases referred to in paragraph 1, second subparagraph, point (f), the Agency shall immediately inform the Commission. The Commission shall in turn inform the relevant national and Union authorities. Where relevant, national authorities shall forward the information to drinking water and wastewater operators. [Am. 131]

Added4. Where the marketing authorisation holder intends to permanently withdraw the marketing authorisation for a critical medicinal product, the marketing authorisation holder shall, prior to the notification referred to in paragraph 1, offer, on reasonable terms, to transfer the marketing authorisation to a third party that has declared its intention to place that critical medicinal product on the market, or to use the pharmaceutical non-clinical and clinical documentation contained in the file of the medicinal product for the purposes of submitting an application in accordance with Article 14 of [revised Directive 2001/83/EC].

Added4a. The Agency may decide to extend obligations set out in paragraph 4 in justified cases to a specific non-critical medicinal product on a case-by-case basis. [Am. 132]

Added4b. The marketing authorisation holder from which the marketing authorisation has been transferred to a third party shall notify the Agency of the transfer as soon as possible. The information regarding the transfer provided shall be made publicly available. [Am. 133]

AddedArticle 25 Duplicate marketing authorisations

Added1. Only one marketing authorisation may be granted to an applicant for a specific medicinal product.

AddedBy way of derogation from the first subparagraph, the Commission shall authorise the same applicant to submit more than one application to the Agency for that medicinal product in either of the following cases:

Added(a) if one of its indications or pharmaceutical forms is protected by a patent or a supplementary protection certificate in one or more Member States;

Added(b) for reasons of co-marketing with a different undertaking not belonging to the same group as the marketing authorisation holder of the medicinal product for which a duplicate is requested.

AddedAs soon as the relevant patent or supplementary protection certificate referred to in point (a) expires, the marketing authorisation holder shall without undue delay withdraw the initial or duplicate marketing authorisation. [Am. 134]

Added2. As regards medicinal products for human use, Article 187(3) of [revised Directive 2001/83/EC] shall apply to medicinal products authorised under this Regulation.

Added3. Without prejudice to the unique Union nature of the content of the documents referred to in Article 12(4), points (a) to (k), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product for human use covered by a single marketing authorisation.

AddedArticle 26 Medicinal products for compassionate use

Added1. By way of derogation from Article 5 of [revised Directive 2001/83/EC] Member States may make available for compassionate use a medicinal product for human use belonging to the categories referred to in Article 3, paragraphs 1 and 2. This may include new therapeutic uses of an authorised medicinal product.

Added2. For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article 3, paragraphs 1 and 2 available for compassionate reasons to a single or group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, treatment resistant, or causing psychological distress or patients in palliative care, and who cannot be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 or the submission of such application is imminent, or it must be undergoing clinical trials in the same indication. [Am. 135]

Added3. When applying paragraph 1, the Member State shall notify the Agency, which shall make the notification publicly available. [Am. 136]

Added4. When compassionate use is envisaged by a Member State, the Committee for Medicinal Products for Human Use, after consulting the manufacturer or the applicant, may adopt opinions on the conditions for use, the conditions for distribution and the patients targeted. The opinions shall be updated where necessary.

AddedIn the preparation of the opinion, the Committee for Medicinal Products for Human Use may request information and data from marketing authorisation holders and from developers and may engage with them in preliminary discussions. The Committee may also make use of health data generated outside of clinical studies, including real world data, where available, taking into account the reliability of those data. [Am. 137]

AddedThe Agency may also liaise with the third country agencies for medicinal products with respect to additional information and data exchanges.

AddedIn the preparation of its opinion, the Committee for Medicinal Products for Human Use may consult the Member State concerned and request it to provide any available information or data that the Member State has in its possession relating to the medicinal product concerned.

Added5. Member States shall take account of any available opinion and notify the Agency of the making available of products on the basis of the opinion in their territory. Member States shall ensure that pharmacovigilance requirements are applied for those products. Article 106, paragraphs 1 and 2, as regards the recording and reporting of suspected adverse reactions and the submission of periodic safety update reports respectively, shall apply mutatis mutandis.

Added6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4 and shall publish it in the database referred to in Article 138(1), second subparagraph, point (n), on its website. [Am. 138]

Added7. The opinions referred to in paragraph 4 shall not affect the civil or criminal liability of the manufacturer or of the applicant for marketing authorisation.

Added8. Where a compassionate use programme has been set up in accordance with paragraphs 1 and 5, the applicant shall ensure that patients taking part also have access to the new medicinal product during the period between authorisation and placing on the market.

Added9. This Article shall be without prejudice to Regulation (EU) No 536/2014 and to Article 3 of [revised Directive 2001/83/EC].

Added10. The Agency mayshall adopt detailed guidelines laying down format and content of notifications referred to in paragraphs 3 and 5, and data exchange under this Article. [Am. 139]

AddedArticle 27 Request for opinion on scientific matters

AddedAt the request of the Executive Director of the Agency or the Commission, the Committee for Medicinal Products for Human Use shall draw up an opinion on any scientific matter concerning the evaluation of medicinal products for human use. That Committee shall take due account of any requests by Member States for an opinion.

AddedThe Agency shall publish the opinion after deletion of any information of a commercially confidential nature.

AddedArticle 28 Regulatory decisions on marketing authorisations

AddedAn authorisation to place a medicinal product covered by this Regulation on the market shall not be granted, refused, varied, suspended, withdrawn or revoked except through the procedures and on the grounds set out in this Regulation.

AddedArticle 29 Regulatory protection periods

AddedWithout prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with this Regulation shall benefit from the periods of regulatory protection set out in Chapter VII of [revised Directive 2001/83/EC].

AddedThe applicable periods of regulatory protection shall be published and updated where appropriate by the Commission in the Union Register of medicinal products. [Am. 140]

AddedSection 3 Temporary emergency marketing authorisation

AddedArticle 30 Temporary emergency marketing authorisation

AddedDuring a public health emergency, the Commission may grant a temporary emergency marketing authorisation (‘TEMA’) for medicinal products intended for the treatment, prevention or medical diagnosis of a serious or life-threatening disease or condition which are directly related to the public health emergency, prior to the submission of the complete quality, non-clinical, clinical data and environmental data and information.

AddedWhere medicinal products containing or consisting of genetically modified organisms in the sense of Article 2(2) of Directive 2001/18/EC are concerned, Articles 13 to 24 of that Directive shall not apply.

AddedAn application for a temporary emergency marketing authorisation shall be submitted in accordance with Articles 5 and 6.

AddedArticle 31 Criteria for granting a temporary emergency marketing authorisation

AddedA temporary emergency marketing authorisation may be granted only after the recognition of a public health emergency at Union level in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council and where the following requirements are met:

Added(a) there is no other satisfactory method of treatment, prevention or diagnosis authorised or sufficiently available in the Union or, if such method is already available, the temporary emergency marketing authorisation of the medicinal product will contribute to address the public health emergency;

Added(b) based on the scientific evidence available, the Agency issues an opinion concluding that the medicinal product could be effective in treating, preventing or diagnosing the disease or condition directly related to the public health emergency, and the known and potential benefits of the product outweigh the known and potential risks of the product, taking into consideration the threat posed by the public health emergency.

AddedArticle 32 Scientific opinion

Added1. The Agency shall ensure that the scientific opinion of the Committee for Medicinal Products for Human Use is given without undue delay, taking into account, the recommendation of the Emergency Task Force referred to in Article 38(1), second subparagraph. For the purpose of issuing its opinion, the Agency may consider any relevant data on the medicinal product concerned in addition to the evidence submitted in the applicant’s dossier. [Am. 141]

Added2. The Agency shall without undue delay review any new evidence provided by the developer, the Member States or the Commission, or any other additional evidence that comes to its attention, taking into account the evidence submitted by the developer, in particular evidence that might influence the benefit-risk balance of the medicinal product concerned. [Am. 142]

AddedThe Agency shall update its scientific opinion as necessary.

Added3. The Agency shall transmit without undue delay to the Commission the scientific opinion and its updates and any recommendations on the temporary emergency marketing authorisation. The scientific opinion and information on the application for the use of the temporary emergency marketing authorisation shall be made publicly available by the Agency. [Am. 143]

AddedArticle 33 Commission decision for a temporary emergency marketing authorisation

Added1. On the basis of the scientific opinion of the Agency or its updates referred to in Article 32, paragraphs 1 and 2, the Commission shall, by means of implementing acts, take a decision without undue delay on the temporary emergency marketing authorisation of the medicinal product subject to the specific conditions set in accordance with paragraphs 2, 3 and 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Added2. On the basis of the scientific opinion of the Agency referred to in paragraph 1, the Commission shall set specific conditions with respect to the temporary emergency marketing authorisation, in particular the conditions for manufacturing, use, supply and safety monitoring and the compliance with related good manufacturing, and pharmacovigilance practices. If necessary, the conditions may specify the batches of the medicinal product concerned by the temporary emergency marketing authorisation, after consultation with the applicant or marketing authorisation holder. [Am. 144]

Added3. Specific conditions may be set to require the completion of ongoing studies or to conduct new studies to ensure the safe and effective use of the medicinal product or minimise its impact on the environment. A time limit for the submission of those studies shall be set.