What changed between the plenary report and the adopted text

Removed:Article 178 – paragraph 1 – point b – point ii: (ii) the information necessary for correct use and disposal of the medicinal product;

Added:(32) ‘risk management plan’ means a detailed description of the risk management system;

Removed:Article 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.

Added:(33) ‘environmental risk assessment’ means the evaluation of the risks to the environment, or risks to public health, posed by the release of the medicinal product in the environment from the manufacturing, use and disposal of the medicinal product and the identification of risk prevention, limitation and mitigation measures. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product; [Am. 107]

Removed:Article 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.

Added:(34) ‘antimicrobial resistance’ means the ability of a micro-organism to survive or to grow in the presence of a concentration of an antimicrobial agent that is usually or was previously sufficient to inhibit or kill that micro-organism; [Am. 108]

Removed:Article 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;

Added:(35) ‘risks related to use of the medicinal product’ means any risk:

Removed:Article 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.

Added:(a) relating to the quality, safety or efficacy of the medicinal product as regards patients' health or public health;

Removed:Article 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.

Added:(b) of undesirable effects on the environment posed by the medicinal product;

Removed:Article 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.

Added:(c) of undesirable effects on public health due to the release of the medicinal product in the environment including anti-microbial resistance;

Removed:Article 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.

Added:(36) ‘active substance master file’ means a document that contains a detailed description of the manufacturing process, quality control during manufacture and process validation prepared in a separate document by the manufacturer of the active substance;

Removed:Article 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.

Added:(37) ‘paediatric investigation plan’ means a research and development programme aimed at ensuring that the necessary data are generated determining the conditions in which a medicinal product may be authorised to treat the paediatric population;

Removed:Article 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.

Added:(38) ‘paediatric population’ means that part of the population aged between birth and 18 years;

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

Added:(39) ‘medicinal prescription’ means any medicinal prescription issued by a professional person qualified to do so;

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

Added:(40) ‘abuse of medicinal products’ means persistent or sporadic, intentional excessive use of medicinal products that is accompanied by harmful physical or psychological effects;

Removed:Article 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:

Added:(41) ‘benefit-risk balance’ means an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks referred to in point (35), subpoint (a);

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

Added:(42) ‘marketing authorisation holder representative’ means the person, commonly known as local representative, designated by the marketing authorisation holder to represent the marketing authorisation holder in the Member State concerned;

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

Added:(43) ‘package leaflet’ means information for the user that accompanies the medicinal product;

Removed:Article 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.

Added:(44) ‘outer packaging’ means the packaging into which is placed the immediate packaging;

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

Added:(45) ‘immediate packaging’ means the container or other form of packaging immediately in contact with the medicinal product;

Removed:Article 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.

Added:(46) ‘labelling’ means information on the immediate packaging or the outer packaging;

Removed:Article 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.

Added:(47) ‘name of the medicinal product’ means the name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or by the name of the marketing authorisation holder;

Removed:Article 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.

Added:(48) ‘common name’ means the international non-proprietary name recommended by the World Health Organization for an active substance;

Removed:Article 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.

Added:(49) ‘strength of the medicinal product’ means the content of the active substances in a medicinal product, expressed quantitatively per dosage unit, per unit of volume or per unit of weight according to the dosage form;

Removed:Article 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].

Added:(50) ‘falsified medicinal product’ means any medicinal product with a false representation of:

Removed:Article 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.

Added:(a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients or the strength of those ingredients;

Removed:Article 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.

Added:(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or

Removed:Article 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.

Added:(c) its history, including the records and documents relating to the distribution channels used;

Removed:Article 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;

Added:This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights.

Removed:Article 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.

Added:(51) ‘public health emergency’ means a public health emergency recognised at Union level by the Commission under Article 23(1) of Regulation (EU) 2022/2371 of the European Parliament and of the Council;

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

Added:(52) ‘entity not engaged in an economic activity’ means any legal or natural person that is not engaged in an economic activity and that:

Removed:Article 207 – paragraph 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.

Added:(a) is not an undertaking or controlled by an undertaking; and,

Removed:Article 207 – paragraph 1 a (new): 1a. By ... [18 months from 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 or private actors, or both, responsible for the collection systems referred to in paragraph 1.

Added:(b) has not concluded any agreements with any undertaking concerning sponsorship or participation to the medicinal product development;