Changes from report parliamentary committee draft to plenary report

AddedArticle 178 – paragraph 1 – point b – point iii: (iii) an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, as the case may be, and to consult a medical practitioner or a pharmacist for additional information.

RemovedArticle 195 – paragraph 2: 2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend or vary a marketing authorisation if a serious risk to the environment, including public health, has been identified and not sufficiently addressed by the marketing authorisation holder. The competent authorities of the Member States or, in the case of a centralised marketing authorisation, the Commission may revoke a marketing authorisation in such cases only if it deems that those risks clearly outweigh the loss of positive therapeutic effects of the medicinal product for the concerned patient population and the risks cannot be mitigated following a decision of suspension or modification.

AddedArticle 178 – paragraph 2 a (new): 2a. The Commission shall adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying requirements in relation to direct and indirect advertising of medicinal products through social media and other media platforms and product placements by celebrities and influencers.

RemovedArticle 206 – paragraph 2 – point e a (new): (ea) non-compliance with the obligations laid down in Article 58a shall be subject to the imposition of effective, proportionate and dissuasive financial penalties.

AddedArticle 179 – paragraph 1 – point h: (h) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural or not chemical;

AddedArticle 183 – paragraph 1: 1. Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons.

AddedArticle 185 – paragraph 1 – point g: (g) no samples of medicinal products containing substances classified as antibiotic, psychotropic or narcotic within the meaning of international conventions may be supplied.

AddedArticle 186 – paragraph 1: 1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. At least for advertisements targeted at the general public, such methods shall be based on a system of prior vetting, and shall in any event include legal provisions under which persons or organisations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Chapter, may take legal action against such advertisement, or bring such advertisement before the competent authority of the Member State either to decide on complaints or to initiate appropriate legal proceedings.

AddedArticle 186 – paragraph 4 a (new): 4a. Member States shall set up and maintain a national transparency register of transfers of value regarding the advertising activities referred to in Articles 175, 177, 180 and 182 to 185, targeting persons qualified to prescribe medicinal products. The Commission shall publish on its website a list referring to all national registries.

AddedArticle 186 – paragraph 4 b (new): 4b. The national registries referred to in paragraph 4a of this Article shall include at least the following information: / (a) the name of the marketing authorisation holder; / (b) the name of a person qualified to prescribe medicinal products; / (c) the medicinal product concerned; / (d) the type of advertising activity, referred to in Article 175(1), second subparagraph, points (b) to (g) and Article 184; / (e) the monetary value.

AddedArticle 186 – paragraph 4 c (new): 4c. Marketing authorisation holders shall use the national transparency register referred to in paragraph 4a to submit the information referred to in paragraph 4b in relation to each person qualified to prescribe medicinal products in the Member State where such activity takes place.

AddedArticle 186 – paragraph 5: 5. Paragraphs 1 to 4c shall not exclude the voluntary control of advertising of medicinal products by self-regulatory bodies.

AddedArticle 187 – paragraph 2 – point d a (new): (da) report activities in national registries, as laid down in Article 186 (4c).

AddedArticle 188 – paragraph 5 – introductory part: 5. Where the competent authority of the Member State considers it necessary, in particular where there are grounds for suspecting non-compliance with the rules of this Directive, including with the principles of good manufacturing practice and good distribution practices, referred to in Articles 160 and 161, or based on a risk assessment, it may have its official representatives carry out the measures referred to in paragraph 1, second subparagraph at the premises or on the activities of:

AddedArticle 188 – paragraph 5 – point d: (d) distributors of medicinal products or manufacturers or distributors of active substances located in third countries;

AddedArticle 188 – paragraph 5 a (new): 5a. The Agency shall draw up guidelines on the use of the Union database.

AddedArticle 193 – paragraph 2: 2. 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.

AddedArticle 194 – title: Processes for the preparation of medicinal products derived from substances of human origin

AddedArticle 194 – paragraph 1: 1. Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from substances of human origin are properly validated, attain batch-to-batch consistency and guarantee, insofar as the state of technology permits, the absence of relevant risks for human health, including contaminations.

AddedArticle 194 – paragraph 2: 2. To this end manufacturers shall notify the competent authorities of the Member States of the methods used to ensure the quality and safety of the substances of human origin, as set out in Regulation (EU) 2024/...[SoHO Regulation]. 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.

AddedArticle 195 – paragraph 2: 2. 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.

AddedArticle 196 – paragraph 1 – point f: (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.

AddedArticle 200 – paragraph 2: 2. 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].

AddedArticle 200 – paragraph 4 – subparagraph 1: 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.

AddedArticle 201 – paragraph 1: 1. 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.

AddedArticle 201 – paragraph 2 a (new): 2a. 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.

AddedArticle 206 – paragraph 1 a (new): 1a. When determining the type and level of penalties to be imposed in the case of infringements, the competent authorities of the Member States shall give due regard to all relevant circumstances of the specific infringement and to the following: / (a) the nature, gravity and extent of the infringement; / (b) the repetitive or singular character of the infringement; / (c) where appropriate, the intentional or negligent character of the infringement; / (d) any action taken by the infringing party to mitigate or remedy the damage caused; / (e) the level of cooperation with the competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;

AddedArticle 206 – paragraph 2 – point e a (new): (ea) non-compliance with the obligations set out in Article 58a shall be subject to the imposition of effective, proportionate and dissuasive financial penalties.

Article 207 – title: Collection and management of unused or expired medicinal products

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ChangedArticle 207 – paragraph 1: 1. Member States shall ensure that appropriate collection and management systems are in place for medicinal products that are unused or have expired and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment.

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ChangedArticle 207 – paragraph 1 a (new): 1a. By ... [18 months afterfrom the date of entry into force of this Directive], Member States shall draw up national plans including measures designed to: / (a) monitor the rates of correct and incorrect disposal of unused and expired medicinal products; / (b) inform the general public about the environmental risks associated with incorrect disposal of medicinal products, in particular those that contain substances referred to in Article 22(2); / (c) inform healthcare professionals about the environmental risks associated with incorrect disposal of unused or expired medicinal products, in particular those that contain substances referred to in Article 22(2); / (d) increase the rate of correct disposal of unused or expired medicinal products; and / (e) designate public andor private actorsactors, or both, responsible for the collection systems referred to in paragraph 1.

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ChangedArticle 207 – paragraph 1 b (new): 1b. The nationalMember plansStates shall besubmit submittedthe national plans to the Commission.

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RemovedArticle 207 – paragraph 1 c (new): 1c. From ... [five years after the date of entry into force of this Directive], the Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 1a of this Article by supplementing or modifying the measures provided for in that paragraph if it is necessary to minimise the environmental risks posed by incorrect disposal of unused or expired medicinal products.

AddedArticle 208 – paragraph 1: 1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no direct or indirect financial or other interests in the pharmaceutical industry that could affect their impartiality and their independence. These persons shall make an annual declaration of their financial interests and update them annually and whenever necessary. The declaration shall be made available upon request.

RemovedArticle 215 – paragraph 2 – subparagraph 1: The power to adopt delegated acts referred to in Articles 4(2), 24(5), 25(9), 26(3), 26a(4), 27(3), 28(2) and (3), 58a(1), 63(4a), 65(2), 67(2), 88(1), 92(4), 126(1), 150(3), 153(4), 161, 207(1c), 210(4) and 213 shall be conferred on the Commission for a period of five years from [OP please insert the date of the entry into force of this Directive]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

AddedArticle 208 – paragraph 2: 2. In addition, the Member States shall ensure that the competent authority makes publicly available its rules of procedure and those of its committees, including their working groups and expert groups, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions.

RemovedArticle 215 – paragraph 3: 3. The delegation of power referred to in Articles 4(2), 24(5), 25(9), 26(3), 26a(4), 27(3), 28(2) and (3), 58a(1), 63(4a), 65(2), 67(2), 88(1), 92(4), 126(1), 150(3), 153(4), 161, 207(1c), 210(4) and 213 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

AddedArticle 214 – paragraph 4: 4. The rules of procedure, lists of participating entities of its meetings, agendas for its meetings and records of its meetings, accompanied by decisions taken, and, where applicable, details of votes and explanations of votes, including minority opinions, of the Standing Committee on Medicinal Products shall be made publicly available.

RemovedArticle 215 – paragraph 6: 6. A delegated act adopted pursuant to Articles 6(2), 26(3), 24(5), 26a(4), 27(3), 28(2) and (3), 58a(1), 63(4a), 65(2), 67(2), 88(1), 92(4), 126(1), 150(3), 153(4), 161, 207(1c), 210(4) and 213 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

AddedArticle 216 – paragraph 1: By [OP please insert the date = 10 years following 18 months after the date of entering into force of this Directive], the Commission shall present a report to the European Parliament and the Council on the application of this Directive, including an assessment of the fulfilment of its objectives and the resources required to implement it, including regarding the revised framework for regulatory data protection periods.

AddedArticle 216 – paragraph 1 a (new): 1a. By ...[2 years from the date of entry into force of this Directive], the Commission shall submit a report to the European Parliament and Council evaluating the appropriateness of the framework of homeopathic products, in particular aspects of public health and patient protection. The report shall, where appropriate, be accompanied by a legislative proposal.

AddedArticle 216 a (new): Article 216a / Fostering research on, and innovation and production of, medicinal products in the Union / 1. The Commission shall establish a strategy on fostering research on, and innovation and production of, medicinal products in the Union, based on the results published in the report provided for paragraph 2. Member States shall be encouraged to participate in that strategy. / 2. By... [two years from the date of entry into force of this Directive] the Commission shall present an impact assessment evaluating potential measures to be implemented at Union level and at a Member State level to foster research on, and innovation and production of, critical medicinal products in the Union. That report shall evaluate the effect of measures such as: / (a) funding and push and pull incentives directed to foster research and innovation in the Union, including public and private funding for preclinical and clinical research and innovation; / (b) public-private partnerships in research and innovation; / (c) regulatory support for public research and innovation entities; / (d) incentives for production of critical medicinal products within the Union. / Any proposed measures shall be in line with the development of the strategic autonomy of the Union regarding medicinal products.

AddedAnnex I – point 21 – point a – introductory part: a) an antimicrobial stewardship and access plan which shall in particular outline:

AddedAnnex I – point 21 – point a – point ii a (new): (iia) information about measures for a strategy to promote access, including proposed production chain capacity;

AddedAnnex I – point 21 – point a – point ii b (new): (iib) information about measures to ensure marketing approvals are received for key territories in a timely manner; and

AddedAnnex I – point 21 – point a – point ii c (new): (iic) information about measures to monitor effectiveness of stewardship and access.

Annex IV – paragraph 1 – point a: (a) the name of the medicinal product, including in Braille, followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the medicinal product contains up to three active substances, the international non-proprietary name (INN) shall be included, unless it is already part of the name of the medicinal product, or, if one does not exist, the common name;

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AddedAnnex IV – paragraph 1 – point g a (new): (ga) for antimicrobials, a warning that improper use and unsafe disposal of the medicinal product contributes to antimicrobial resistance;

AddedAnnex IV – paragraph 1 – point j: (j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products as well as reference to any appropriate collection system in place;

AddedAnnex V – paragraph 1 – point 6 – point f: (f) special precautions for disposal of a medicinal product or waste materials derived from such medicinal product as well as any designated collection system in place. In case of antimicrobial medicinal products in addition to the precautions a warning that inappropriate disposal of the medicinal product contributes to antimicrobial resistance;

Annex VI – paragraph 1 – point 2 a (new): (2a) a key information section reflecting the results of consultations with patients’ organisations to ensure that the leaflet is legible, clear and easy to use;

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AddedAnnex VI – paragraph 1 – point 4 – point b: (b) the method and, if necessary, route of administration, and where relevant a description of the measuring or delivery device, as well as the relevant individual steps of medicine preparation and administration;

AddedAnnex VI – paragraph 2 a (new): The package leaflet may also contain information on the importance of therapeutic adherence and available support for adherence in the Member State.