What changed between the plenary report and the adopted text

Removed:Article 130 – paragraph 2 – point a: (a) the price of the homeopathic product;

Added:(17) ‘multi-medicinal product package’ means a package that contains more than one medicinal product under a single invented name and intended to be used in a medical treatment where the individual medicinal products in the package are for medical purposes simultaneously or sequentially administered;

Removed:Article 131 – title: Advertising of homeopathic products

Added:(18) ‘radiopharmaceutical’ means any medicinal product that, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose;

Removed:Article 131 – paragraph 1: 1. Chapter XIII shall apply to homeopathic products.

Added:(19) ‘radionuclide generator’ means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceutical;

Removed:Article 131 – paragraph 2 – subparagraph 1: By derogation from paragraph 1, Article 176(1) shall not apply to homeopathic products referred to in Article 126(1).

Added:(20) ‘kit’ means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration;

Removed:Article 131 – paragraph 2 – subparagraph 2: However, only the information specified in Article 130(1) may be used in the advertising of such homeopathic products.

Added:(21) ‘radionuclide precursor’ means any other radionuclide produced for the radio-labelling of another substance prior to administration;

Removed:Article 132 – title: Exchange of information on homeopathic products

Added:(22) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals and, antifungals and antiprotozoals; [Am. 99]

Removed:Article 132 – paragraph 1: Member States shall communicate to each other all the information necessary to guarantee the quality and safety of homeopathic products manufactured and marketed within the Union, and in particular the information referred to in Articles 202 and 203.

Added:(23) ‘integral combination of a medicinal product with a medical device’ means a combination of a medicinal product with a medical device, as defined by Regulation (EU) 2017/745, and where:

Removed:Article 133 – title: Other requirements for homeopathic products

Added:(a) the two form an integral product and where the action of the medicinal product is principal and not ancillary to that of the medical device, or

Removed:Article 133 – paragraph 1: 1. Homeopathic products other than those referred to in Article 126(1) shall be granted a marketing authorisation in accordance with Articles 6 and 9 to 14 and labelled in accordance with Chapter VI.

Added:(b) the medicinal product is intended to be administered by the medical device and the two are placed on the market in such a way that they form a single integral product that is intended exclusively for use in the given combination and where the medical device is not reusable.

Removed:Article 133 – paragraph 2 – subparagraph 1: A Member State may introduce or retain in its territory specific rules for the non-clinical tests and clinical studies of homeopathic products other than those referred to in Article 126(1), in accordance with the principles and characteristics of homeopathy as practised in that Member State.

Added:(24) ‘combined advanced therapy medicinal products’ means a product as defined in Article 2 of Regulation (EC) No 1394/2007, including when a gene therapy medicinal product is part of the combined advanced therapy medicinal product;

Removed:Article 133 – paragraph 3: 3. Chapter IX shall apply to homeopathic products, with the exception of those referred to in Article 126(1). Chapter XI, Chapter XII, Section 1, and Chapter XIV shall apply to homeopathic products.

Added:(25) ‘medicinal product in exclusive use with a medical device’ means a medicinal product presented in a package with a medical device or to be used with a specific medical device, as defined by Regulation (EU) 2017/745, and referenced in the summary of product characteristics;

Removed:Article 140 – paragraph 2 – subparagraph 1 – point b: (b) the user should consult a doctor or a qualified healthcare practitioner if the symptoms persist during the use of the traditional herbal medicinal product or if adverse effects occur; and

Added:(26) ‘combination of a medicinal product with a product other than a medical device’ means a combination of a medicinal product with a product other than a medical device (as defined by Regulation (EU) 2017/745 and Regulation (EU) 2017/746 of the European Parliament and of the Council) and where the two are intended for use in the given combination in accordance with the summary of product characteristics; [Am. 100]

Removed:Article 140 – paragraph 2 – subparagraph 1 – point b a (new): (ba) the user consult a doctor or a qualified healthcare practitioner for information about possible contraindications or pharmacological interactions with other medications.

Added:(27) ‘immunological medicinal product’ means:

Removed:Article 140 – paragraph 3: 3. In addition to the requirements set out in Chapter XIII, any advertisement for a traditional herbal medicinal product registered under this Section shall contain the following statement: Traditional herbal medicinal product for use in specified therapeutic indication(s) exclusively based upon long-standing use. For more information, consult a healthcare professional.

Added:(a) any vaccine or allergen product, or

Removed:Article 142 – paragraph 3 – point a: (a) preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail and hospital supply, by pharmacists in dispensing pharmacies or by persons legally authorised in the Member States to carry out such processes; or

Added:(b) any medicinal product consisting of toxins or serums used to produce passive immunity or to diagnose the state of immunity;

Removed:Article 147 – paragraph 1 – subparagraph 1 – point j a (new): (ja) use an appropriate wastewater treatment system;

Added:(28) 'vaccine’ means any medicinal product that is intended to elicit an immune response for prevention, including post exposure prophylaxis, and for treatment of diseases caused by an infectious agent;

Removed:Article 147 – paragraph 1 – subparagraph 1 – point j b (new): (jb) comply with relevant risk mitigation measures identified in accordance with Article 22.

Added:(29) ‘gene therapy medicinal product’ means a type 1 or type 2 medicinal product, except vaccines against infectious diseases, that contains or consists of:;

Removed:Article 148 – paragraph 9: 9. Where relevant, competent authorities of the Member State supervising the central and decentralised sites shall liaise with the competent authority of the Member State responsible for the supervision of the marketing authorisation.

Added:(a) a substance or a combination of substances intended to edit the host genome in a sequence-specific manner or that contain or consists of cells subjected to such modification; or

Removed:Article 160 – paragraph 1 – introductory part: The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying:

Added:(b) a recombinant or synthetic nucleic acid used in or administered to human beings with a view to regulating, replacing or adding a genetic sequence that mediates its effect by transcription or translation of the transferred genetic materials or that contain or consists of cells subjected to these modifications; [Am. 101]

Removed:Article 160 – paragraph 1 – point b a (new): (ba) measures to reduce the negative impact on the environment posed by the manufacturing of medicinal products.

Added:(29a) “type 1 gene therapy medicinal product” means a medicinal product that contains or consists of a substance or a combination of substances that edit the host genome in a sequence-specific manner or that contain or consists of cells subjected to such modification; [Am. 102]

Removed:Article 163 – paragraph 1: 1. The competent authority of the Member State concerned shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to an authorisation to engage in activity as a wholesaler in medicinal products (“wholesale distribution authorisation”). The wholesale distribution authorisation shall indicate the premises, the categories of medicinal products and the wholesale distribution operations for which it is valid.

Added:(29b) “type 2 gene therapy medicinal product” means a medicinal product, except a vaccine against infectious disease that contains or consists of a recombinant or synthetic nucleic acid used in or administered to human beings with a view to regulating, replacing or adding a genetic sequence that mediates its effect by transcription or translation of the transferred genetic materials or that contain or consists of cells subjected to these modifications; [Am. 103]

Removed:Article 166 – paragraph 1 – point m: (m) cooperate with all relevant stakeholders, including marketing authorisation holders and competent authorities of the Member States on the security of supply.

Added:(30) ‘somatic cell therapy medicinal product’ means a biological medicinal product that has the following characteristics:

Removed:Article 168 – paragraph 1 – introductory part: 1. For all supplies of medicinal products to a person authorised or entitled to supply medicinal products to the public in the Member State concerned, the authorised wholesaler shall provide a document, which may be submitted in electronic format, that makes it possible to ascertain the following:

Added:(a) contains or consists of cells or tissues that have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or of cells or tissues that are not intended to be used for the same essential function(s) in the recipient and the donor;

Removed:Article 172 – paragraph 1 – point a: (a) the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established and complies, where applicable, with the conditions referred to in paragraph 2 of this Article;

Added:(b) is presented as having properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.

Removed:Article 175 – paragraph 1 – subparagraph 2 – point e: (e) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind;

Added:For the purposes of point (a), the manipulations listed in Annex I to Regulation (EC) No 1394/2007, in particular, shall not be considered as substantial manipulations.

Removed:Article 176 – paragraph 3 – point b a (new): (ba) shall not induce to an excessive or abusive use of the medicinal product.

Added:(30a) ‘platform technology’ means a technology or collection of technologies that is comprehensive, well-characterised, reproducible and used to support the development, manufacturing process, quality control, or testing of medicinal products or their components that rely on prior knowledge and are established under the same underlying scientific principles; [Am. 104]

Removed:Article 176 – paragraph 4: 4. Any form of advertising that aims to highlight negatively another medicinal product shall be prohibited. Advertising that suggests that a medicinal product is safer or more effective than another medicinal product shall also be prohibited, unless demonstrated and supported by the summary of product characteristics for the relevant indications and patient population.

Added:(30b) ‘platform technology master file’ means a document, prepared by the owner of the platform technology, that contains data of a platform technology for which the underlying scientific principles, under which the platform technology is established, have reasonable scientific certainty to remain unchanged across medicinal products and to apply regardless of components added to the platform for a medicinal product; [Am. 105]

Removed:Article 177 – paragraph 1 – point b a (new): (ba) are antibiotics or antimicrobials for which there is an identified risk of antimicrobial resistance as referred to in Article 51(1a).

Added:(31) ‘SoHO-derived medicinal product other than ATMPs’ means any medicinal product containing, consisting of or deriving from a substance of human origin (SoHO), as defined in Regulation [SoHO Regulation], other than tissues and cells, that is of standardised consistency and is prepared by:

Removed:Article 177 – paragraph 2: 2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a healthcare professional for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.

Added:(a) a method involving an industrial process which includes pooling of donations, for purposes beyond processing of substances of human origin for concentrates or pathogen inactivation; or [Am. 106]

Removed:Article 177 – paragraph 4: 4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns approved by the competent authorities of the Member States.

Added:(b) a process that extracts an active ingredient from the substance of human origin or transforms the substance of human origin by changing its inherent properties;