Authorisation to Manufacture Medicinal Products – Requirements, Application and Chief Pharmaceutical Inspector (GIF) Inspection

Manufacturing a medicinal product in the European Union is a regulated activity. A manufacturing site, equipment and a formulation are not enough – an administrative decision is required to confirm that the facility meets the requirements of Good Manufacturing Practice (GMP). Without it, no batch of a medicine may legally be placed on the market, even if the product has a valid marketing authorisation.

For a brand owner planning to launch a medicine, this is one of the first strategic decisions: whether to build your own manufacturing facility or use a facility that already holds an authorisation. Below you will find what genuinely determines this choice – the scope of the obligation, required documentation, costs, timelines and the course of an inspection by the Chief Pharmaceutical Inspector. If you are considering an outsourcing model, also see how contract manufacturing of medicines works.

Who must obtain an authorisation and what it covers

Commencing activities involving the manufacture or import of a medicinal product requires an authorisation issued by the Chief Pharmaceutical Inspector. The legal basis is Article 38 of the Act of 6 September 2001 – Pharmaceutical Law. The obligation covers not only the manufacture of the pharmaceutical form, but the entire chain of activities leading to the finished product.

The authorisation relates to a specific place of business and a specific scope of activities. In practice, it covers:

• manufacture of non-sterile or sterile products – both scopes are priced and inspected separately because they differ in the requirements for premises and processes;
• packaging and repackaging operations – including those performed on a product manufactured by another entity;
• batch release – activities reserved for the Qualified Person employed by the manufacturer;
• import of a medicinal product from outside the European Economic Area – treated as a separate scope of the authorisation.

This is a fundamental difference compared with the dietary supplements market, where placing a product on the market is based on notification to the Chief Sanitary Inspector, rather than on a decision authorising the facility. The pharmaceutical regime is incomparably stricter here – and its financial consequences are worth calculating before the project even begins.

Application, documentation and review deadline

The application is submitted using the official template, and its core component is the Site Master File. This is a standardised description of the facility: organisational structure, quality system, premises, equipment, processes, quality control and activities outsourced to external entities. The inspector reads this document before the visit and uses it as the basis for planning the scope of the inspection.

The application must also be accompanied by a list of medicinal products with their name, strength and pharmaceutical form, the details of the Qualified Person and proof of payment of the fee. If the matter is handled by an attorney-in-fact, an additional stamp duty of PLN 17 applies.

The Chief Pharmaceutical Inspector issues the authorisation or a refusal decision within 90 days from the date of submission of the application. This period does not run while waiting for supplements and explanations, so in practice incomplete documentation can extend the proceedings by further months. The quality of the Site Master File therefore directly affects the date of the first commercial batch.

GIF inspection and GMP certificate

Before issuing the authorisation, the authority may carry out an inspection to verify whether the applicant actually meets the conditions for conducting the activity. The detailed requirements are set out in the Regulation of the Minister of Health of 9 November 2015 on Good Manufacturing Practice requirements, the annexes to which correspond to the EU GMP guidelines.

Inspectors focus on areas where an error translates directly into patient safety: the layout and classification of premises, the flow of materials and personnel, equipment qualification, process and cleaning validation, quality control of materials and completeness of batch documentation. Identified non-conformities are classified according to severity, and a critical non-conformity means no authorisation will be granted or manufacturing will be suspended until corrective actions have been implemented.

The mere fact of holding a manufacturing authorisation does not yet mean obtaining a GMP certificate. A positive inspection result concludes with the issuance of this document and its publication in the European EudraGMDP database. The certificate is publicly verifiable – every business partner and regulatory authority can easily check its scope and validity. You can find more about the role of both of these formalities in the quality chain in the article on GMP and ISO 22000:2018 certificates, while the manufacturing rules themselves are discussed in the text on the 10 principles of Good Manufacturing Practice.

Own manufacturing facility or contract partner – what to choose

A brand owner who outsources manufacturing does not need its own authorisation. This obligation rests with the manufacturer, while your role is limited to being the marketing authorisation holder in whose name the marketing authorisation is issued. We support brand owners in obtaining this decision as part of our medicine registration service.

The calculation is usually straightforward. Building your own manufacturing facility means investing in premises with controlled cleanliness, equipment qualification, hiring a Qualified Person and maintaining a quality system – all before the first saleable batch is produced. The contract model shifts this burden to a partner that spreads the cost of maintaining the authorisation across many projects simultaneously.

When choosing a manufacturer, check three things: the scope of the authorisation in relation to your pharmaceutical form, the current validity of the GMP certificate in EudraGMDP and the facility’s readiness to carry out the technology transfer of your process – what such cooperation looks like step by step. These three elements determine whether the project starts within a quarter or within a year.

Use a facility that has held an authorisation for years

Obtaining your own manufacturing authorisation is a multi-year project with a budget counted in millions. Outsourcing production to a partner with a current GMP certificate shortens this path to a discussion about the formulation, scale and schedule. Eubioco, together with Laboratorium Galenowe Olsztyn, combines more than 30 years of pharmaceutical practice with complete R&D, quality control and regulatory documentation facilities. Are you planning to launch a medicine under your own brand? Contact our experts at sprzedaz@eubioco.eu to discuss the scope of cooperation and receive an individual quotation.

BIBLIOGRAPHY

1. Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2001, No. 126, item 1381, as amended), Article 38 et seq.
2. Regulation of the Minister of Health of 9 November 2015 on Good Manufacturing Practice requirements (Journal of Laws of 2022, item 1273, as amended – Journal of Laws of 2024, item 1816).
3. 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), Articles 40–53.
4. Chief Pharmaceutical Inspectorate (2026). Issuance of an authorisation to manufacture or import a medicinal product. [online] Available at: https://www.gov.pl/web/gif/wydanie-zezwolenia-na-wytwarzanie-lub-import-produktu-leczniczego [accessed online: 11.08.2026]
5. Biznes.gov.pl (2026). Manufacture or import of a medicinal product. [online] Available at: https://www.biznes.gov.pl/pl/portal/ou195 [accessed online: 11.08.2026]