Changes from plenary report to adopted text

AddedSection 2 Controls

AddedArticle 191 Controls on medicinal products

AddedMember States shall take all appropriate measures to ensure that the marketing authorisation holder for a medicinal product and, where appropriate, the manufacturing authorisation holder, furnish proof of the controls carried out on the medicinal product or the ingredients and of the controls carried out at an intermediate stage of the manufacturing process, in accordance with the methods laid down in Annex I.

AddedArticle 192 Submission of control reports for immunological medicinal products

AddedFor the purpose of implementing Article 191, Member States may require manufacturers of immunological products to submit to a competent authority of the Member States copies of all the control reports signed by the qualified person in accordance with Article 153.

AddedArticle 193 Batch control of specific medicinal product by Member States

Added1. Where it considers it necessary in the interests of public health, a Member State may require the marketing authorisation holder of:

Added(a) live vaccines,

Added(b) immunological medicinal products used in the primary immunisation of infants or of other groups at risk,

Added(c) immunological medicinal products used in public health immunisation programmes,

Added(d) new immunological medicinal products or immunological medicinal products manufactured using new or altered kinds of technology or new for a particular manufacturer, during a transitional period normally specified in the marketing authorisation,

Addedto submit samples from each batch of the bulk or the medicinal product for examination by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before release on to the market unless the competent authority of another Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. In such a case the declaration of conformity issued by another Member States shall be directly recognised. Member States shall ensure that any such examination is completed within 30 days of the receipt of the samples.

Added2. Where, in the interests of public health, the laws of a Member State so provide, the competent authorities of the Member State may require the marketing authorisation holder for medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk or the medicinal product for testing by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before being released into free circulation, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. In such a case the declaration of conformity issued by another Member State shall be recognised. Member States shall ensure that any such examination is completed within 60 days of the receipt of the samples. [Am. 306]

AddedArticle 194 Processes for the preparation of medicinal products derived from human blood orsubstances of human plasmaorigin [Am. 307]

Added1. Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from human blood orsubstances of human plasmaorigin are properly validated, attain batch-to-batch consistency and guarantee, insofar as the state of technology permits, the absence of specific viral contaminationrelevant risks for human health, including contaminations. [Am. 308]

Added2. To this end manufacturers shall notify the competent authorities of the Member States of the methodmethods used to reduce or eliminate pathogenic viruses liable to be transmitted by medicinal products derived fromensure the quality and safety of the substances of human blood or human plasmaorigin, as set out in Regulation (EU) 2024/1938. The competent authority of the Member State may submit samples of the bulk or the medicinal product for testing by a State laboratory or a laboratory designated for that purpose, either during the examination of the application pursuant to Article 29, or after a marketing authorisation has been granted. [Am. 309]

AddedChapter XV Restrictions of marketing authorisations

AddedArticle 195 Suspending, revoking or varying the terms of marketing authorisations

Added1. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission shall suspend, revoke or vary a marketing authorisation if the view is taken that the medicinal product is harmful or that it lacks therapeutic efficacy, or that the benefit-risk balance is not favourable, or that its qualitative and quantitative composition is not as declared. Therapeutic efficacy shall be considered to be lacking when it is concluded that therapeutic results cannot be obtained from the medicinal product.

Added2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder and if the risks cannot be mitigated through the grant of the conditions specified in Articles 44(1), first subparagraph, point (h), or 87(1), first subparagraph, point (c), following a decision of suspension or modification. Any such decision shall take into account the clinical benefits of the medicinal product and the needs of patients, including alternative treatments available. [Am. 310]

Added3. A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 6, 9 to 14 or Annexes I to V are incorrect or have not been amended in accordance with Article 90, or where any conditions referred to in Articles 44, 45 and 87 have not been fulfilled or where the controls referred to in Article 191 have not been carried out.

Added4. Paragraph 2 also applies in cases where the manufacture of the medicinal product is not carried out in compliance with the particulars provided pursuant to Annex I, or where controls are not carried out in compliance with the control methods described pursuant to Annex I.

Added5. The competent authorities of the Member State or, in the case of centralised marketing authorisation, the Commission shall suspend or revoke the marketing authorisation for a category of preparations or all preparations where any one of the requirements laid down in Article 143 is no longer met.

AddedArticle 196 Prohibition of supply or withdrawal of a medicinal product from the market

Added1. Without prejudice to the measures provided for in Article 195, the competent authorities of the Member States and, in the case of centralised marketing authorisation, the Commission shall take all appropriate steps to ensure that the supply of the medicinal product is prohibited and the medicinal product withdrawn from the market, if the view is taken that:

Added(a) the medicinal product is harmful;

Added(b) it lacks therapeutic efficacy;

Added(c) the benefit-risk balance is not favourable;

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 through the grant of the conditions specified in Articles 44(1), first subparagraph, point (h), or 87(1), first subparagraph, point (c); any such decision shall also take into account the clinical benefits of the medicinal product and the needs of patients, including alternative treatments available. [Am. 311]

Added2. The competent authority of the Member State or, in the case of centralised marketing authorisation, the Commission may limit the prohibition to supply the product, or its withdrawal from the market, to those batches that are the subject of dispute.

Added3. The competent authority of the Member State or, in the case of centralised marketing authorisation, the Commission may, for a medicinal product for which the supply has been prohibited or that has been withdrawn from the market in accordance with paragraphs 1 and 2, in exceptional circumstances during a transitional period allow the supply of the medicinal product to patients who are already being treated with the medicinal product.

AddedArticle 197 Suspected falsified medicinal products and medicinal products with suspected quality defects

Added1. Member States shall have a system in place that aims at preventing medicinal products that are suspected to present a danger to health from reaching the patient.

Added2. The system referred to in paragraph 1 shall cover the receipt and handling of notifications of suspected falsified medicinal products as well as of medicinal products with suspected quality defects. The system shall also cover recalls of medicinal products by marketing authorisation holders or withdrawals of medicinal products from the market ordered by competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission from all relevant actors in the supply chain both during and outside normal working hours. The system shall also make it possible to recall, where necessary with the assistance of health professionals, medicinal products from patients who received such products.

Added3. If the medicinal product in question is suspected of presenting a serious risk to public health, the competent authority of the Member State in which that product was first identified shall, without undue delay, transmit a rapid alert notification to all Member States and all actors in the supply chain in that Member State. In the event of such medicinal products being deemed to have reached patients, urgent public announcements shall be issued within 24 hours in order to recall those medicinal products from the patients. Those announcements shall contain sufficient information on the suspected quality defect or falsification and the risks involved.

AddedArticle 198 Suspending or revoking manufacturing authorisation

AddedIn addition to the measures specified in Article 196, the competent authority of the Member State may suspend manufacture or imports of medicinal products coming from third countries, or suspend or revoke the manufacturing authorisation for a category of preparations or all preparations where Articles 144, 147, 153 and 191 are not complied with.

AddedArticle 199 Refusal, suspension or revocation within the limits of the Directive

Added1. An authorisation to market a medicinal product shall not be refused, suspended or revoked except on the grounds set out in this Directive.

Added2. No decision concerning suspension of manufacture or of importation of medicinal products coming from third countries, prohibition of supply or withdrawal from the market of a medicinal product may be taken except on the grounds set out in Articles 195(5) and 196.

AddedChapter XVI General provisions

AddedArticle 200 Competent authorities of the Member States

Added1. Member States shall designate the competent authorities to carry out tasks under this Directive.

Added2. Member States shall ensure that adequate financial resources are available to provide the staff and other resources, including appropriate digital infrastructure, necessary for the competent authorities to carry out the activities required by this Directive and [revised Regulation (EC) No 726/2004]. [Am. 312]

Added3. The competent authorities of the Member States shall cooperate with each other and with the Agency and the Commission in the performance of their tasks under this Directive and [revised Regulation (EC) No 726/2004] to ensure proper application and due enforcement. The competent authorities of the Member States shall transmit to each other all necessary information.

Added4. The competent authority of the Member State may process personal health data from sources other than clinical studies, including real world data, to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder. [Am. 313]

AddedProcessing of personal data under this Directive shall be subject to Regulations (EU) 2016/679 and (EU) 2018/1725, as applicable.

AddedArticle 201 Cooperation with other authorities

Added1. Member States, in applying this Directive, shall ensure that when questions arise with regard to the regulatory status of a medicinal product, in relation to their link to substances of human origin as referred to in Regulation (EU) No [SoHO Regulation], the competent authorities of the Member States shall consult the Agency and the relevant authorities established under that Regulation. [Am. 314]

Added2. Member States, in applying this Directive, shall take the necessary measures to ensure cooperation between competent authorities for medicinal products and customs authorities.

Added2a. In order to improve regulatory certainty and cross-sectoral cooperation, the Commission shall, where necessary, organise joint meetings between the Agency and the relevant advisory and regulatory bodies established under other Union legislation to assess, for the purposes of this Directive, emerging trends and questions on the regulatory status of products and to find agreement on common regulatory status principles. The summaries and conclusions of those joint meetings shall be made publicly available, including the opinions and conclusions of each of the respective bodies. [Am. 315]

AddedArticle 202 Member States exchange of information of manufacturing or wholesale distribution authorisations of medicinal products

Added1. Member States shall take all appropriate measures to ensure that the competent authorities of the Member States concerned communicate to each other such information as is appropriate to guarantee that the requirements placed on the authorisations referred to in Articles 142 and 163, on the certificates referred to in Article 188(13) or on the marketing authorisations are fulfilled.

Added2. Upon reasoned request, Member States shall send electronically the report referred to in with Article 188 to the competent authorities of another Member State or to the Agency.

Added3. The conclusions reached in accordance with Articles 188(13) or 188(14) shall be valid throughout the Union.

Added4. 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 188(1), that Member State shall without undue delay inform the Commission and the Agency. The Agency shall inform the Member States concerned.

Added5. 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 that are not parties to the disagreement.

AddedArticle 203 Information on prohibition of supply or other action on a marketing authorisation