Below is an attempt to provide information with the intention of facilitating a better understanding of the progress with the update to the EU pharmaceutical legislation.
The proposed revision of the pharmaceutical legislation will consist of two legislative proposals:
- a new directive, repealing and replacing Directive 2001/83/EC and Directive 2009/35/EC of the European Parliament and of the Council and incorporating relevant parts of the Paediatric Regulation (Regulation (EC) No 1901/2006)
- a new regulation, repealing and replacing Regulation (EC) No 726/2004, repealing and replacing the Orphan Regulation (Regulation (EC) No 141/2000) and repealing and incorporating relevant parts of the Paediatric Regulation (EC) No 1901/2006).
The merger of the Orphan Regulation and the Paediatric Regulation with the legislation applicable to all medicinal products will allow for simplification and increased coherence.
When did the Council adopt the final pharma package?
The Council adopted the ‘pharma package’ on 28 September 2026, a new set of rules that will increase patient access to medicine and make the EU’s pharmaceutical sector fairer and more competitive.1 On the same day, the updated texts of the proposed the new Directive and Regulation were published.
What are some of the key elements in the propsed Directive?
Some of the key elements of the proposed Directive are provided in Table 1 below.
For a better understanding of the proposed changes, refer to the articles to which links have been provided in the Further Reading section.
Table 1
| Subject | Article no(s) in the current Directive and/or Regulation(s) | Article no(s) in the proposed Directive and/or Regulation | Notes |
|---|---|---|---|
| Antimicrobial resistance | Proposed Directive Articles 40(1), Article 41(4), Article 42(1), Article 43(1)(b) | The pharma package introduces a new transferable exclusivity voucher incentivising pharmaceutical companies to help combat antimicrobial resistance by developing priority antibiotics. This voucher will grant companies one additional year of market protection for a pharmaceutical product of their choice.1 The voucher will be subject to a ‘blockbuster clause’, which limits the potential impact on national healthcare budgets by stipulating that the transferable voucher cannot be used on products with annual gross sales of more than €490 million in the preceding four years.1 | |
| Specific requirements on the making available and supply of a medicinal product in a Member State | Proposed Directive Article 59 | To ensure the availability of key medicines, EU countries will have the power to require pharmaceutical companies to supply medicines benefiting from regulatory protection in sufficient quantities to meet patient needs. Safeguards have been introduced to ensure that this supply obligation is used to meet the needs of patients as opposed to facilitating ‘parallel trade’ (i.e. cheaper exports to other member states).1 | |
| Orphan medicinal products | Regulation (EC) No 141/2000 and Regulation (EC) No 847/2000 | Proposed Regulation Article 72 (defines breakthrough medicinal products), 73(1), (2)(a), 2(b) and 2(c), | Under the new rules, orphan medicinal products that are developed to treat rare conditions will receive nine years of market exclusivity. So-called ‘breakthrough’ orphan medicines may be granted an additional two years of market exclusivity, bringing the total up to eleven years. An orphan medicine will be considered ‘breakthrough’ if: – no medicinal product has thus far been authorised in the EU to treat the relevant orphan condition – the medicine leads to a clinically relevant reduction in sickness or mortality rates resulting from that condition.1 There will be four years of market exclusivity for orphan medicinal products which have been authorised in accordance with Article 14 of Directive (EU) 2026/…+ i.e. have been in well established use for at least 10 years within the Union. |
| Regulatory data and market protection | Article 10(1) of consolidated Directive 2001/83/EC Article 14(11) of Regulation (EC) No 726/2004 8 + 2 + 1 8 yrs of regulatory data protection 8 + 2 =10 yrs of market protection + 1 additional year of market protection if within the 8 years of regulatory data protection, a marketing authorisation is obtained for one or more new therapeutic indications for those medicines which are demonstrated to bring a significant clinical benefit in comparison to existing therapies | Proposed Directive Articles 83(1) and 83(2), Article 84 and Article 85 (defines unmet medical need) (8 + 1) + 1+ 1 8 years of regulatory data protection 8+1 = 9 years of market protection + 1 additional year of market protection may be obtained for products where an applicant demonstrates that the medicinal product addresses an unmet medical need as referred to in Article 85 or for medicinal products containing a new active substance, where the marketing authorisation applicant demonstrates that: i) the clinical trials supporting the initial MAA use a relevant and evidence-based comparator in accordance with the scientific advice provided by the Agency and ii) the MAA has been submitted first to the competent authority in the Union or has been submitted no later than 90 days of the submission of the application for the first marketing authorisation outside the Union; or (c) where the MA applicant demonstrates that: (i) the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with the scientific advice provided by the Agency; and (ii) clinical trials evaluating the efficacy of the medicinal product and used for the marketing authorisation were conducted in more than one Member State; or (d) where the MA applicant justifies that a clinical trial as referred to in points (b) (i) and (c) (i) is not possible or appropriate and demonstrates that: (i) clinical trials evaluating the efficacy of the medicinal product and used for the marketing authorisation were conducted in more than one Member State; and (ii) the marketing authorisation application has been submitted first to the competent authority in the Union or has been submitted no later than 90 days of the submission of the application for the first marketing authorisation outside the Union. + 1 The regulatory market protection period shall be extended by an additional year if, during the regulatory data protection period referred to in Article 83(1), the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation and based on supporting data submitted by the marketing authorisation holder, are held to bring a significant clinical benefit in comparison with existing therapies. This extension may only be granted once. The total combined period of protection allocated to a new medicinal product cannot exceed eleven years. | |
| The Bolar exemption | Article 10(6) of consolidated Directive 2001/83/EC | Proposed Directive Articles 87(1) and 87(2) | The pharma package includes an intellectual property exemption allowing manufacturers to take the necessary steps (such as studies or trials) to ensure that generic versions of a medicine can be made available on day one after the intellectual property rights have expired. The scope of this provision will include the submission of applications for procurement tenders.1 Refer to the Further Reading section for links to articles on the Bolar Exemption. |
Next steps
The regulation and directive that make up the pharma package now need to be adopted by the European Parliament. They will then enter into force following publication in the EU’s Official Journal.1
There is no official timing available, but it is anticipated that the new legislation will be published sometime in Nov-Dec 2026.
The Regulation and Directive will come into into force 20 days after publication in the Official Journal. and generally, most of the provisions are expected to become applicable 24 months thereafter.
Read the EU Pharma Package: When Will the New Rules Apply? by Elisabet Cots et al, 12 October 2026 of Baker McKenzie to get a tentative idea of when all of the above could happen.
Where can you track the progress of the proposed legislation?
You can track the progress with the proposed Directive here and the proposed Regulation here.
Table 2 below is an attempt to provide a comparison of some of the Articles of Directive 2001/83/EC with the Articles from the proposed Directive. Note that the proposed test is not final yet.
Table 2
| Current Consolidated Directive 2001/83/EC | Proposed Directive 28 September 2026 ST-7106-2026-REV-2 |
|---|---|
| Article 8 | Article 6 – General requirements for marketing authorisation applications |
| Article 12 | Article 7 Expert verification of detailed summaries |
| SECTION 2 SPECIFIC REQUIREMENTS FOR ABRIDGED, BIBLIOGRAPHIC OR CONSENT BASED APPLICATIONS FOR MARKETING AUTHORISATION | |
| Article 10 1. By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community. A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product. The first subparagraph shall also apply if the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application form the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month, a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference product and if necessary other relevant documentation. The ten-year period referred to in the second subparagraph shall be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies. 2. For the purposes of this Article: (a) ‘reference medicinal product’ shall mean a medicinal product authorised under Article 6, in accordance with the provisions of Article 8; (b) ‘generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines. ………………………….etc. | Article 10 Marketing authorisation applications concerning generic medicinal products 1. By way of derogation from Article 7(2), the applicant for a marketing authorisation for a generic medicinal product shall not be required to provide to the competent authorities of the Member States or the Agency, as applicable, the results of non-clinical tests and of clinical studies if equivalence of the generic medicinal product with the reference medicinal product is demonstrated. 2. For the purpose of demonstrating the equivalence of a generic medicinal product as referred to in paragraph 1, the marketing authorisation applicant shall: (a) submit equivalence studies to the competent authorities of the Member States or the Agency, as applicable, or provide a justification as to why such studies were not performed, and (b) demonstrate that the generic medicinal product meets the relevant criteria set out in the relevant detailed guidelines. 3. Paragraph 1 shall also apply if the reference medicinal product has not been authorised in the Member State in which the marketing authorisation application for the generic medicinal product is submitted. In this case, the marketing authorisation applicant shall indicate in the marketing authorisation application for the generic medicinal product the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the marketing authorisation application for the generic medicinal product is submitted, the competent authority of the other Member State shall transmit within a period of one month a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference medicinal product and, if necessary, any other relevant documentation. The various immediate-release oral pharmaceutical forms shall be considered to be the same pharmaceutical form. 4. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy. The marketing authorisation applicant for the generic medicinal product shall submit additional information to demonstrate that the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance do not differ significantly in respect of those properties. 5. Where there is a significant difference in properties as referred to in paragraph 4, the applicant shall submit additional information in order to demonstrate the safety or efficacy of the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of the authorised active substance of the reference medicinal product in a marketing authorisation application under Article 11. |
| Article 10(3) 3. In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided. | Article 11 Marketing authorisation applications for hybrid medicinal products In case of a marketing authorisation application for a medicinal product which does not fall within the definition of a generic medicinal product or differs in strength, pharmaceutical form, route of administration or therapeutic indications compared to the reference medicinal product (‘hybrid medicinal product’), the results of the relevant non-clinical tests or clinical studies shall be provided to the competent authorities of the Member States or the Agency, as applicable, to the extent necessary to establish a scientific bridge to the data relied upon in the marketing authorisation for the reference medicinal product, and to demonstrate the safety and efficacy profile of the hybrid medicinal product. |
| Article 10(4) 4. Where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I and the related detailed guidelines. The results of other tests and trials from the reference medicinal product’s dossier shall not be provided. | Article 12 Marketing authorisation applications for biosimilar medicinal products For a biosimilar medicinal product, the results of appropriate comparability tests and studies shall be provided to the competent authorities of the Member States or the Agency, as applicable. The type and quantity of supplementary data to be provided shall comply with the relevant criteria set out in Annex II and the related detailed guidelines. The results of other tests and studies from the reference medicinal product’s dossier shall not be required. |
| Aricle 10(6) Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products. | Article 87 Exception relating to intellectual property rights 1. The protection provided by patent rights or supplementary protection certificates for medicinal products shall not be regarded as infringed when the necessary studies, trials and other activities are conducted for the purposes of: (a) obtaining marketing authorisations, in particular for generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations; (b) conducting health technology assessments as defined in Article 2, point (5), of Regulation (EU) 2021/2282; (c) obtaining pricing and reimbursement approvals; (d) complying with subsequent practical requirements associated with activities referred to in points (a), (b) and (c); (e) submitting an application on procurement tenders, in compliance with Union and national law, to the extent that it does not entail the sale or offering for sale or marketing of the medicinal product concerned during the protection period provided by patent rights or supplementary protection certificates The activities conducted exclusively for the purposes set out in the first subparagraph may cover, where relevant, the submission of a marketing authorisation application and the offer, manufacture, sale, supply, storage, import, use and purchase of medicinal products or processes, including by third party suppliers and service providers. 2. Decisions adopted concerning the activities referred to in paragraph 1 shall not be considered as infringing intellectual property rights, within the meaning of that paragraph. The intellectual property rights on the reference medicinal product shall not represent a valid ground to refuse, revoke or suspend decisions adopted concerning the activities referred to in paragraph 1. 3. The exception provided for in this Article shall not cover the placing on the market of the medicinal products resulting from such activities |
| Article 13 Marketing authorisation applications for bio-hybrid medicinal products In cases where the biological medicinal product does not fall within the definition of a biosimilar medicinal product or differs in strength, pharmaceutical form, route of administration or therapeutic indications compared to the reference biological medicinal product (‘bio-hybrid medicinal product’), the results of the appropriate non-clinical tests or clinical studies shall be provided to the competent authorities of the Member States or the Agency, as applicable, to the extent necessary to establish a scientific bridge to the data relied upon in the marketing authorisation for the reference biological medicinal product, and to demonstrate the safety and efficacy profile of the bio-hybrid medicinal product. | |
| Article 10a By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the test and trial results shall be replaced by appropriate scientific literature. | Article 14 Marketing authorisation applications based on bibliographic data The marketing authorisation applicant shall, by way of derogation from Article 7(2), not be required to provide the results of non-clinical tests or clinical studies if the marketing authorisation applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In such cases, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature, and the marketing authorisation applicant shall establish a scientific bridge between the bibliographic data and the medicinal product concerned. Marketing authorisation applications based on this Article shall only be submitted provided that the marketing authorisation applicant demonstrates that: (a) at the time of submission of the marketing authorisation application, no reference medicinal product is or has been authorised in the Union for the active substance of the medicinal product concerned; (b) while a reference medicinal product has been authorised in the Union for the active substance of the medicinal product concerned, it is not available on the market within the Union at the time of submission of the marketing authorisation application; or (c) the marketing authorisation application concerns a herbal medicinal product for which efficacy and safety have been established and documented in a relevant Union herbal monograph |
| Article 10c Following the granting of a marketing authorisation, the authorisation holder may allow use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal product, with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form. | Article 15 Marketing authorisation applications based on consent Following the granting of a marketing authorisation, the marketing authorisation holder may, by letter of access, allow use to be made of all documentation referred to in Article 7(2) for the purpose of examining marketing authorisation applications relating to other medicinal products with the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form. |
| SECTION 3 SPECIFIC REQUIREMENTS FOR APPLICATIONS FOR CERTAIN CATEGORIES OF MEDICINAL PRODUCTS | |
| Article 10b In the case of medicinal products containing active substances used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes, the results of new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with Article 8(3)(i), but it shall not be necessary to provide scientific references relating to each individual active substance. | Article 16 Fixed-dose combination medicinal products, platform marketing authorisation and multi-medicinal product packages 1. Where duly justified for clinical purposes, a marketing authorisation may be granted for a fixed-dose combination medicinal product. 2. Where duly justified for clinical purposes, a marketing authorisation may be granted for a medicinal product comprised of a fixed component and a variable component that is pre-defined in order to, where appropriate, target different variants of an infectious agent or, where necessary, to tailor the medicinal product to characteristics of an individual patient or a group of patients (‘platform marketing authorisation’). Before submitting a marketing authorisation application for such a medicinal product, the applicant shall obtain the agreement of the competent authority of the Member State or the Agency, as applicable, for the submission of the application. 3. Where justified for public health reasons, a marketing authorisation may be granted, in exceptional circumstances, for a multi-medicinal product package where the active substances cannot be combined within a fixed- dose combination medicinal product. Before submitting a marketing authorisation application for such a multi-medicinal product package, the applicant shall obtain the agreement of the competent authority of the Member State or the Agency, as applicable, for the submission of the application. |
| Article 19 Integral combinations of a medicinal product with a medical device | |
| Article 20 Medicinal products in exclusive use with a medical device or with an in vitro diagnostic medical devices | |
| Article 21 Combinations of medicinal products with products other than medical devices | |
| Chapter V Article 56a Specific requirements on making available and supplying of a medicinal product in a Member State | |
| TITLE V LABELLING AND PACKAGE LEAFLET | Chapter VI Product Information |
| Article 59 Specific requirements on the making available and supply of a medicinal product in a Member State | |
| Article 54 The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging: (a) the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, if one does not exist, the common name; (b) a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names; (c) the pharmaceutical form and the contents by weight, by volume or by number of doses of the product; (d) a list of those excipients known to have a recognized action or effect and included in the detailed guidance◄ published pursuant to Article 65. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated; (e) the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated; (f) a special warning that the medicinal product must be stored out of the reach and sight of children; (g) a special warning, if this is necessary for the medicinal product; (h) the expiry date in clear terms (month/year); (i) special storage precautions, if any; (j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place; (k) the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him; (l) the number of the authorization for placing the medicinal product on the market; (m) the manufacturer’s batch number; (n) in the case of non-prescription medicinal products, instructions for use; (o) for medicinal products other than radiopharmaceuticals referred to in Article 54a(1), safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to: — verify the authenticity of the medicinal product, and — identify individual packs, as well as a device allowing verification of whether the outer packaging has been tampered with. | Article 68 Labelling on the outer or immediate packaging 1. Labelling particulars listed in Annex IV shall appear on the outer packaging of medicinal products or, where there is no outer packaging, the immediate packaging, with the exception of the packaging referred to in Article 69, paragraphs 2 and 3. 2. The Commission is empowered to adopt delegated acts in accordance with Article 218 to: (a) amend the list of labelling particulars set out in Annex IV in order to take account of scientific progress or patients’ needs; (b) supplement Annex IV by setting out a reduced list of mandatory labelling particulars that shall appear on the outer packaging of multi-country packages that are also multilingual Annex IV – Labelling particulars The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging: (a) the name of the medicinal product, including in Braille, followed by its strength, if appropriate, including in Braille and by its pharmaceutical form, if appropriate, including in Braille, and, if appropriate, whether it is intended for babies, children or adults; (b) where the medicinal product contains up to three active substances, the international non-proprietary name (INN), unless it is already part of the name of the medicinal product, or, if there is no INN, the common name; (c) a statement of the active substances expressed qualitatively and quantitatively per dose or unit or according to the form of administration for a given volume or weight, using their common names; (d) the pharmaceutical form and the contents by weight, by volume or by number of doses of the medicinal product; (e) a list of those excipients known to have a recognised action or effect and included in the detailed guidance published pursuant to Article 80; (f) the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated; (g) a special warning that the medicinal product must be stored out of the reach and sight of children; (h) a special warning, if necessary for the medicinal product; (i) the expiry date in clear terms (month/year); (j) special storage precautions, if any; (k) 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; (l) the name and address of the marketing authorisation holder and, where applicable, the name of the marketing authorisation holder representative; (m) the marketing authorisation number; (n) the manufacturer’s batch number; (o) in the case of medicinal products not subject to medical prescription, instructions for use; (p) for medicinal products other than radiopharmaceuticals referred to in Article 70(1), safety features enabling manufacturers, wholesale distributors, pharmacists and other natural or legal persons authorised or entitled to supply medicinal products to the public and the competent authorities of the Member States or the Agency, as applicable, to: (i) verify the authenticity of the medicinal product, and (ii) identify individual packs, as well as a device allowing verification of whether the outer packaging has been tampered with. |
Article 55 1. The particulars laid down in Article 54 shall appear on immediate packagings other than those referred to in paragraphs 2 and 3. 2. The following particulars at least shall appear on immediate packagings which take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Articles 54 and 62. — the name of the medicinal product as laid down in point (a) of Article 54, — the name of the holder of the authorization for placing the product on the market, — the expiry date, — the batch number. 3. The following particulars at least shall appear on small immediate packaging units on which the particulars laid down in Articles 54 and 62 cannot be displayed: — the name of the medicinal product as laid down in point (a) of Article 54 and, if necessary, the route of administration, — the method of administration, — the expiry date, — the batch number, — the contents by weight, by volume or by unit. | Article 69 Labelling on blister packs or small immediate packaging 1. The labelling particulars listed in Annex IV shall appear on immediate packaging other than immediate packaging referred to in paragraphs 2 and 3. 2. On immediate packaging that takes the form of blister packs and that is placed in an outer packaging that complies with the requirements laid down in Articles 68 and 76, at least the following particulars shall appear: (a) the name of the medicinal product; (b) the name of the marketing authorisation holder placing the product on the market; (c) the expiry date; (d) the batch number. 3. On small immediate packaging units on which the particulars laid down in Articles 68 and 76 cannot be displayed, at least the following particulars shall appear: (a) the name of the medicinal product and, if necessary, the route of administration; (b) the method of administration, if not already evident from the name of the medicinal product or from the route of administration of the medicinal product, as referred to in point (a); (c) the expiry date; (d) the batch number; (e) the contents by weight, by volume or by unit. |
| Article 56a The name of the medicinal product, as referred to in Article 54, point (a) must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package information leaflet is made available on request from patients’ organisations in formats appropriate for the blind and partially-sighted. | Article 74 Accessibility for persons with disabilities The name of the medicinal product, followed by its strength, if appropriate, and pharmaceutical form, if appropriate, shall also be expressed in Braille format on the outer packaging. The marketing authorisation holder shall ensure that the package leaflet referred to in Article 66 is made available free of charge upon request from patients’ organisations in formats appropriate for persons with disabilities, including blind and partially-sighted persons. |
| Article 57 | Article 75 Member States labelling requirements |
| Article 58 | Article 66 General principles for package leaflets 1. A package leaflet shall be mandatory for medicinal products. The package leaflet shall be made available by the marketing authorisation holder in the packaging in paper format and electronically in accordance with the specifications, standards and format specified by the implementing acts adopted pursuant to paragraph 6. 2. The package leaflet shall be written and designed in a clear and understandable way, enabling users to act appropriately, when necessary with the help of healthcare professionals. 3. By derogation from paragraph 1, Member States may decide, for specific categories of medicinal products or for all medicinal products, following a consultation of patients, healthcare professionals and other relevant stakeholders, that marketing authorisation holders are only required to make available an electronic version of the package leaflet. If a Member State decides that marketing authorisation holders are only required to make available an electronic version of the package leaflet: (a) the patient’s right to a printed copy of the package leaflet shall be guaranteed upon request and free of charge; (b) it shall not preclude the marketing authorisation holder from providing the package leaflet in paper format in addition to the electronic version on a voluntary basis. It shall be ensured that the information in digital format is easily accessible to all patients. The marketing authorisation holder shall be responsible for preparing the electronic version of the package leaflet and ensuring that the electronic and printed versions of the package leaflet are made readily available to the patient. The obligation to make available the package leaflet in paper format in the packaging in a Member State shall not constitute a reason justifying a refusal by the marketing authorisation holder to supply the medicinal product on the market in that Member State. By derogation from paragraphs 1 and 2 of this Article, where the information requiredunder Articles 67 and 76 appears on the outer packaging or on the immediate packaging, a package leaflet shall not be required. The Commission shall by … [18 months from the date of entry into force of the Directive] adopt implementing acts to: (a) establish common standards and formats for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies; (b) establish criteria for the provision of the product information referred to in point (a) by the marketing authorisation holder through secure digital platforms and digital services and for the provision, establishment, management and accessibility of such digital platforms and services; (c) establish the necessary procedures to validate the electronic version of the package leaflet and to make them available to patients; (d) specify information on the packaging on how to access the electronic version of the package leaflet; (e) specify the details on how to include the commonly recognised global antimicrobial resistance symbol as referred to in Article 72(2) in the section of the package leaflet that contains specific information about the medicinal product concerned and information on antimicrobial resistance and on the importance of appropriate use and disposal of antimicrobials. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 217(2). 7. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 217(2). 8. When accessing the package leaflet electronically, the protection of personal data shall be ensured. Any technology giving access to the information shall ensure the protection of personal data in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC and shall not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes, including for advertising or marketing activities. |
| Article 59 | Article 67 Content of package leaflet The package leaflet shall be drawn up in accordance with the summary of product characteristics referred to in Article 65(1) and shall include the particulars listed in Annex VI. The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use |
| Article 60 | Article 81 Placing on the market of labelled medicinal products |
| Article 61 | Article 79 Approval of the labelling and package leaflet |
| Article 62 | Article 76 Symbols and pictogram |
| Article 10(1) of Directive 2001/83/EC Article 14(11) of Regulation (EC) No 726/2004 | Chapter VII Regulatory data protection and regulatory market protection, unmet medical need and rewards for paediatric medicinal products Article 83 Regulatory data protection and regulatory market protection 1. Where a marketing authorisation has been granted for a medicinal product in accordance with Article 7(2) of this Directive, the data referred to in Annex I that were submitted with a view to obtaining that marketing authorisation shall not be referred to by another marketing authorisation applicant for a subsequent marketing authorisation for a period of eight years from the date when the marketing authorisation for that medicinal product was granted, or nine years from that date in cases where one additional year of data protection is granted in accordance with Article 41(1) of Regulation (EU) 2026/…+ (‘regulatory data protection period’). For marketing authorisations that belong to the same global marketing authorisation in accordance with Article 6(2) of this Directive, the regulatory data protection period shall start from the date when the initial marketing authorisation was granted in the Union. 2. A medicinal product covered by a subsequent marketing authorisation referred to in paragraph 1 shall not be placed on the market for a period of one year after the expiry of regulatory data protection period (‘regulatory market protection period’). The regulatory market protection period may be extended in accordance with Article 84. 3. By way of derogation from paragraph 1, the marketing authorisation holder concerned may grant the marketing authorisation applicant for another marketing authorisation access to its data submitted in accordance with Annex I by means of a letter of access in accordance with Article 15. 4. By way of derogation from paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union pursuant to Regulation (EU) 2025/2645 or to national compulsory licensing frameworks, the regulatory data protection and regulatory market protection with regard to that licensee shall be suspended to the extent required by the compulsory licence and for the duration and territory of the Member States for which the compulsory licence has been granted. 5. The regulatory data protection period shall also apply in Member States where the medicinal product is not authorised or is no longer authorised. 6. The competent authorities of the Member States shall make available on their website the list of medicinal products for which they have granted a national marketing authorisation and that are protected by regulatory data protection and regulatory market protection, indicating the applicable extension in accordance with Article 84. The Agency shall compile and publish a list of hyperlinks to the websites referred to in this paragraph. |
| Article 84 Additional regulatory market protection periods 1. The regulatory market protection period referred to in Article 83(2) shall be extended by 12 months: (a) where, at the time of the initial marketing authorisation application, the marketing authorisation applicant demonstrates that the medicinal product addresses an unmet medical need as referred to in Article 85; or (b) for medicinal products containing a new active substance, where the marketing authorisation applicant demonstrates that: (i) the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with the scientific advice provided by the Agency; and (ii) the marketing authorisation application has been submitted first to the competent authority in the Union or has been submitted no later than 90 days of the submission of the application for the first marketing authorisation outside the Union; or (c) for medicinal products containing a new active substance, where the marketing authorisation applicant demonstrates that: (i) the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with the scientific advice provided by the Agency; and (ii) clinical trials evaluating the efficacy of the medicinal product and used for the marketing authorisation were conducted in more than one Member State; or (d) for medicinal products containing a new active substance, where the marketing authorisation applicant justifies that a clinical trial as referred to in points (b)(i) and (c)(i) is not possible or appropriate and demonstrates that (i) clinical trials evaluating the efficacy of the medicinal product and used for the marketing authorisation were conducted in more than one Member State; and (ii) the marketing authorisation application has been submitted first to the competent authority in the Union or has been submitted no later than 90 days of the submission of the application for the first marketing authorisation outside the Union. In the case of a conditional marketing authorisation granted in accordance with Article 20 of Regulation (EU) 2026/…+ , the extension referred to in the first subparagraph, point (a), shall only apply if: – within four years of the granting of the conditional marketing authorisation, the medicinal product has been granted a marketing authorisation in accordance with Article 20(7) of Regulation (EU) 2026/…+ ; and – in the case of medicinal products referred to in Article 85(1), point (b), of this Directive, the studies referred to in Article 20(4) of Regulation (EU) 2026/…+ include clinical trials that use, where possible and appropriate, a relevant and evidence-based comparator. 2. The regulatory market protection period shall be extended by an additional year if, during the regulatory data protection period referred to in Article 83(1), the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation and based on supporting data submitted by the marketing authorisation holder, are held to bring a significant clinical benefit in comparison with existing therapies. This extension may only be granted once. 3. The cumulative duration of the regulatory market protection for a medicinal product shall not exceed two years from the date when the regulatory data protection expires, except when one additional year of the regulatory market protection is granted in accordance with paragraph 2. 4. The Agency shall set scientific guidelines on criteria for proposing a relevant and evidence-based comparator for clinical trials, as referred to in paragraph 1, points (b)(i) and (c)(i), taking into account the results of the consultation of the Commission and the authorities or bodies involved in the consultation process referred to in Article 169 of Regulation (EU) 2026/…+ . | |
| Annexex The Directive has Two Annexes | Annexes The Directive has Eight Annexes |
| Annex I – Analytical, Pharmacotoxicological and clinical standards and protocols in respect of testing of medicinal products Annex II on Repealed Directives, with their successive amendments | Annexes – Eight annexes Annex I -Information to be included in the marketing authorisation application Annex II – Analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products Annex III – Conditions of qualification of a qualified person Annex IV – Labelling particulars – See text provided elsewhere in the table following the text for Article 68. Annex V– Contents of Summary of Product Characteristics Annex VI – Contents of package leaflet Annex VII– Areas for adapted frameworks referred to in Article 31 Annex VIII – Correlation Table |
References
1. ‘Pharma package’: Council adopts new rules for a fairer and more competitive EU pharmaceutical sector, Council of the EU, 28 September 2026
Further reading
EU Pharma Package: When Will the New Rules Apply? Elisabet Cots et al, 12 October 2026, Baker McKenzie
EU Pharmaceutical Package Moves Closer to Adoption: Focus on Antimicrobial Resistance,
Nour Saab et al, October 2026, Bird + Bird
A New Era for EU Pharma, Laura Scott et al, 2 October 2026, , William Fry
EU Council adopts new EU Pharma Package, Charleen O’Keeffe et al, 30 September 2026, Matheson LLP
Final text of the reform to the EU Regulatory Framework for Medicinal Products, Libby Amos-Stone et al, 24 September 2028, BioSlice Blog, Arnold& Porter.
The Bolar Exemption in Europe following the EU Pharma Package,
Lindsay Kent, 21 May 2026, Abe[+] Imrar.
The Bolar exemption in European pharmaceutical law and its further development in the EU pharmaceutical package, Dr Christian Tilmans, 12 May 2026International Bar Association,