Medicinal product registration and marketing authorization – procedures and division of responsibilities in contract manufacturing

Placing a medicinal product on the European Union market requires obtaining a marketing authorisation. Without this decision, the medicine cannot be legally sold, regardless of how refined its formulation is and how modern the facility in which it is manufactured may be. Registration is not a formality that closes the project, but a process that must be planned as early as the stage of selecting the composition and choosing the manufacturing partner.

For a brand owner opting for a manufacturing outsourcing model, it is crucial to understand one thing: registration of a medicinal product and its manufacture are two separate legal responsibilities, formalised through an agreement and documentation. This article explains which registration procedures apply in 2026, who is responsible for what, and how contract manufacturing of medicinal products fits into the entire mechanism.

What is a marketing authorisation and who issues it

A marketing authorisation is an administrative decision confirming that a given medicinal product may be placed on  the market. In it, the regulatory authority assesses three pillars: the quality, safety and efficacy of the medicine. Only a positive benefit-risk balance allows the decision to be issued, which includes the product details, its manufacturer and the marketing authorisation holder, as well as the validity period of the authorisation.

In Poland, the competent authority is the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). The legal basis is the Act of 6 September 2001, Pharmaceutical Law, which regulates the placing of medicinal products on the market in Chapter 2, and, at EU level, Directive 2001/83/EC establishing a Community code relating to medicinal products for human use.

The registration application is based on documentation in the CTD (Common Technical Document) format – a standardised, five-module structure covering administrative data, summaries, quality documentation, and non-clinical and clinical data. It is the quality module (module 3) that most closely links registration with the actual manufacturing process, because it describes the composition, manufacturing methods, control and stability of the product.

Four registration procedures – which one to choose

The choice of registration pathway depends on how many markets you plan to sell in and under what model. The EU system provides for four routes that should not be confused:

• national procedure – used when the medicinal product is to be authorised in only one country and does not hold an authorisation in any other EU country; the application is submitted directly to the URPL or another competent Authority;
• mutual recognition procedure (MRP) – applies to a medicinal product already authorised in at least one Member State, which is to be registered in further countries on the basis of an existing reference authorisation;
• decentralised procedure (DCP) – intended for a medicinal product entering the market for the first time simultaneously in several EU Member States, where no prior authorisation yet exists;
• centralised procedure – conducted by the European Medicines Agency (EMA) pursuant to Regulation (EC) No 726/2004; it results in a single authorisation valid throughout the EU and is mandatory, among others, for biotechnological medicines and advanced therapies.

For most generic medicines and OTC products, the practical choice remains the national procedure, MRP or DCP. If you are planning expansion into several markets, a well-thought-out registration sequence can shorten the path to sales by many months. You can find more about the specifics of medicines available without a prescription in our guide to OTC medicines.

Marketing authorisation holder and manufacturer – who is responsible for what

This is the essence of the contract model. The Marketing Authorisation Holder is the company to which the authorisation is issued and which is responsible for placing the medicine on the market, its safety, pharmacovigilance, and compliance with the approved documentation. In the private label model, this entity is usually the brand owner, not the manufacturer.

The manufacturer is an entity holding a manufacturing authorisation and producing the medicine in accordance with the principles of Good Manufacturing Practice. A contract manufacturer acts precisely in this role – it carries out the process, the Qualified Person (QP) releases batches to the market and is responsible for the quality of the manufactured product, but it does not assume the market responsibility of the marketing authorisation holder.

This division must be precisely described in the Quality Agreement, which allocates responsibilities between the client and the manufacturer in every area – from material control, through batch release, to the handling of complaints and recalls. A well-structured quality agreement is a condition of GMP compliance, not an administrative add-on.

How production preparation affects the success of registration

The quality documentation in the application is based directly on processes from the production floor. The regulatory authority expects data from process validation, stability studies and a description of in-process controls – and these are generated in a specific facility, on specific equipment. If the process has not previously been properly transferred and confirmed, the data for the dossier will be incomplete or inconsistent, which prolongs the procedure.

For this reason, registration is in practice the final link in a chain that begins with the technology transfer to the manufacturing facility, after which the manufacturing process is validated. Only a product manufactured in a reproducible and documented manner and released for marketing  in accordance with GMP provides a solid basis for submitting an application.

It is also worth remembering that some requirements, such as serialisation of medicines and the application of anti-tampering safety features, are also carried out by the manufacturer. The contract manufacturer should therefore have the appropriate infrastructure before the first batch reaches the market, as well as a manufacturing authorisation with the appropriate scope.

Registration does not close the subject of documentation. Any subsequent modification of the composition, process or manufacturing site requires a post-authorisation variation, which is worth planning in parallel with the technical work.

Plan registration together with an experienced CDMO partner

Registration of a medicinal product is much easier when the data for the quality documentation is provided by a manufacturer operating to rigorous quality standards, confirmed by a GMP certificate. Laboratorium Galenowe Olsztyn, part of the Eubioco group, supports brand owners at every stage – from selecting the form and formulation, through process validation, to preparing production data for the dossier and providing support in the field of registration of medicinal products. Are you planning to launch a medicine under your own brand? Contact our experts at sprzedaz@eubioco.eu to discuss the project and plan the manufacturing and registration pathway.

BIBLIOGRAPHY

1. Act of 6 September 2001, Pharmaceutical Law (Journal of Laws of 2022, item 2301, as amended; originally Journal of Laws of 2001, No. 126, item 1381).
2. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Official Journal of the EU L 311 of 28.11.2001, p. 67).
3. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products and establishing a European Medicines Agency (Official Journal of the EU L 136 of 30.04.2004, p. 1).
4. Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (2025). European procedures. [online] Available at: https://www.gov.pl/web/urpl/procedury-europejskie3 [accessed online: 14.07.2026]
5. Biznes.gov.pl (2025). Marketing authorisation for a medicinal product. [online] Available at: https://www.biznes.gov.pl/pl/portal/ou41 [accessed online: 14.07.2026]