Publication date: March 31, 2025
In recent years, there has probably been no more dynamically developing market sector than that closely related to the production of drugs, their testing and introduction to consumer circulation. Especially during the COVID-19 pandemic caused by the SARS-CoV-2 coronavirus, all the efforts of pharmacists around the world have been focused on developing an effective formula for a vaccine protecting against infection with this disease, producing it, testing it and making it available to people, and in the longer term on developing a formula for a drug that could be widely used, e.g. in hospitals. No less important at that time were the problems and legal issues related to obtaining permission to produce drugs. In this article, there will be discussed detailed regulations related to the procedure for obtaining consent to manufacture drugs, which is regulated in the Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2024, item 686; amended: Journal of Laws of 2025, item 129), as well as to present the requirements imposed on drug factories in terms of building equipment and production principles, which are regulated in other sub-statutory legal acts.
Issuance of a permit to manufacture or import a medicinal product
A permit to manufacture or import a medicinal product is an administrative decision issued by the Chief Pharmaceutical Inspector and authorizing the conduct of business in the field of manufacturing or importing medicinal products, on the basis of art. 38 section 2 of the Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2024, item 686; amended: Journal of Laws of 2025, item 129), according to which undertaking business activity in the field of manufacturing or importing a medicinal product requires obtaining a permit to manufacture or import a medicinal product. The provisions regulating this matter also apply to other products listed in art. 51a of the same Act. An applicant applying for a permit to manufacture or import a medicinal product submits to the Chancellery of the Chief Pharmaceutical Inspector an application for a permit to manufacture or import a medicinal product in accordance with the regulation of the Minister of Health of April 29, 2019 on the template of an application for a permit to manufacture or import medicinal products (Journal of Laws item 829), to which the following documents should be attached: Main Documentation of the Place of Business prepared in accordance with Annex No. 4 to the regulation of the Minister of Health of November 9, 2015 on Good Manufacturing Practice (Journal of Laws of 2022, item 1273; amended: Journal of Laws of 2024, item 1323 and item 1816); application for a Qualified Person; proof of payment of the fee for submitting an application for a permit to manufacture or import medicinal products, the amount of which is specified in the Regulation of the Minister of Health of 9 July 2015 on the amount and method of charging fees for submitting an application for a permit to manufacture or import a medicinal product or for changing a permit to manufacture or import a medicinal product (Journal of Laws, item 986); a statement on obtaining an entry in the Central Register and Information on Business Activity, if applicable; an extract from the National Court Register or a printout from the Central Information of the National Court Register or a printout from the Central Register and Information on Business Activity (if applicable), current on the date of submission of the application, if applicable.
The application with the required documents may be submitted in paper or electronic form (sent via electronic means of communication – ePUAP, in accordance with art. 39 sec. 4 of the Pharmaceutical Law Act). The submitted documentation is subject to verification in terms of both formal and substantive aspects. Substantive verification of the submitted documents takes place only after a positive formal assessment of the application. If formal deficiencies are found, a request to supplement them is formulated, indicating the legal basis, indicating a deadline of no less than 7 days. If the entrepreneur fails to supplement the formal deficiencies within the specified deadline, the application is left without consideration, in accordance with art. 64 § 2 of the Act of 14 June 1960 – the Code of Administrative Procedure (Journal of Laws of 2024, item 572). If the application requires supplementation necessary for substantive assessment, a request to submit written explanations is formulated, in accordance with art. 50 § 1 of the Code of Administrative Procedure, indicating the deadline for submitting a response. After obtaining a complete set of documents, an inspection date is set, of which the Applicant is informed in a separate letter. General Sanitary Inspectorate issues a decision on issuing or refusing a permit based on the results of the inspection. Before a decision is issued in the case, the Applicant is notified in writing of the intention to terminate the proceedings regarding the issuance of a permit and of the right to inspect the files and to express their opinion on the evidence and materials collected and the requests submitted, within a specified time limit. After receiving the above-mentioned notification, the Applicant may waive his/her right to inspect the case files and to express his/her opinion on the evidence and materials collected and the requests submitted. If the party does not notify the aforementioned withdrawal in writing, the body will issue a decision on the matter after receiving a return acknowledgment of receipt of the notification and after the deadline specified in the notification has passed. The decision will be sent to the Applicant at the company’s registered office address or the address for electronic delivery, referred to in Article 39 § 1 of the Code of Administrative Procedure (depending on the method of submitting the application). It is also possible to collect the documents in person at the General Sanitary Inspectorate registered office/office by a person authorized to represent the company or holding an appropriate power of attorney. At any stage of the proceedings, if the application meets the formal requirements, the party may apply to the body with a request to suspend the proceedings. According to art. 98 § 1 of the Code of Administrative Procedure, the public administration body may suspend the proceedings if the party at whose request the proceedings were initiated requests it, and other parties do not object and it does not threaten the public interest.
The proceedings shall be resumed upon a written request of the party within 3 years from the date of suspension of the proceedings. If the party does not apply for the resumption of the proceedings within this period, the request to initiate the proceedings shall be deemed withdrawn.
The application and the cover letter and all letters addressed to the Chief Pharmaceutical Inspector during the examination of the case must be signed by the person/persons authorized to represent the entity in accordance with the entry in the register of entrepreneurs, i.e. the National Court Register or the Central Register and Information on Economic Activity, or a person acting on the basis of an appropriate power of attorney (art. 32-33 of the Code of Administrative Procedure) signed by the person indicated in the National Court Register. The name of the entity should be provided in accordance with the entry in the National Court Register or the Central Registration and Information on Business. In accordance with Article 33 § 3 of the Code of Administrative Procedure.
The power of attorney must be accompanied by documentation confirming that the person/persons granting the power of attorney on behalf of the entrepreneur were authorized to do so on the date the power of attorney was granted (unless this results from the register of entrepreneurs of the National Court Register or CEIDG). The power of attorney should be submitted in Polish or translated by a sworn translator and should include: the entrepreneur’s designation (the entrepreneur’s company name and registered office address, Court Registry number and/or Tax ID., respectively); first and last name, PESEL number or other data clearly identifying the person/persons authorized to act on behalf of the entrepreneur (attorney’s data); date of granting the power of attorney; subject scope of the power of attorney (e.g. a detailed description of the activities to which the power of attorney authorizes, including submitting an application, e.g. for the issuance/amendment of a permit to manufacture or import a medicinal product, review of files, receipt of an issued decision, etc.); signature of the entrepreneur or person/persons authorized to make declarations of intent on behalf of the entrepreneur (in accordance with the KRS). In accordance with Art. 41 sec. 1 of the Pharmaceutical Law Act, the Main Sanitary Inspectorate issues a permit or a decision to refuse to issue a permit within 90 days of the date of submission of the application. The time limit is suspended if a request for supplements/clarifications is sent to the party or if the proceedings are suspended.
Detailed requirements for drug factories
In addition to the formal and procedural requirements of an application for a permit to manufacture or import a medicinal product, there are a number of other requirements for drug manufacturers, e.g. in terms of building factories, designing and equipping premises. Such issues are regulated, among others, by the above-mentioned regulation of the Minister of Health of 9 November 2015 on the requirements of Good Manufacturing Practice (Journal of Laws of 2022, item 1273; amended: Journal of Laws of 2024, item 1323 and item 1816.); Regulation of the Minister of Labour and Social Policy of 26 September 1997 on general health and safety conditions at work, as well as, to a lesser extent, the Regulation of the Minister of Infrastructure of 12 April 2002 on the technical conditions to be met by buildings and their location. The provisions of these acts regulate in detail, for example, the issue of requirements for the administrative part, warehouses, Quality Control, technical department, maintenance and production. For example, toilets must be easily accessible and adapted to the number of users, and must not have direct connections with production or storage rooms. Sanitary facilities should be equipped with hot and cold water, soap or detergent, dryers or disposable towels. Washbasins and toilets must be easily accessible and separated from rooms in which intermediate products and active substances are manufactured, and must also provide the possibility of washing under a shower or changing clothes, if necessary. Toilets are also referred to in §25-28 of chapter 4 of annex no. 3 to the regulation of the Minister of Labor and Social Policy and §84, 85 and 86 of the regulation of the Minister of Infrastructure. When it comes to BREEAM certificates, they are awarded by the BRE Global system operator, and a BREEAM assessor appears in the certification path, who must be hired to carry out the entire process.
In turn, emergency evacuation lighting must be used in conference rooms, and when determining the width and number of passages, exits and evacuation routes, this number should be determined in relation to the area of the conference rooms (it must be 1 m²/person, while EU standards provide for 2 m²/person). The height of the conference room must be at least 3 – 3.3 meters, it is permissible to reduce this height to no less than 2.5 meters in the case of using a ventilation system or air conditioning, however, in such a case you must obtain the consent of the provincial sanitary inspector; there are no rigid requirements regarding the equipment of the conference room, but the room should have such lighting that will allow for free reading. In addition, in work rooms, a temperature appropriate to the type of work performed (work methods and physical effort required to perform it) of not less than 14 °C (287 K) must be ensured, unless technological considerations do not allow it. In work rooms where light physical work is performed and in office rooms, the temperature cannot be lower than 18 °C (291 K). There should be at least one washbasin for every thirty men or twenty women simultaneously employed in office work or in conditions similar to such work, but not less than one washbasin if the number of employees is smaller. Washbasins should be installed in toilet rooms or in their isolation anterooms. Moreover, the area and height of work rooms should ensure compliance with occupational health and safety requirements, taking into account the type of work performed, the technologies used and the time employees spend in these rooms. Each employee simultaneously employed in permanent work rooms should have at least 13 m 3 of free volume of the room and at least 2 m 2 of free floor space (not occupied by technical devices, equipment, etc.). Windows, skylights and sidelights in work rooms with high air humidity should be made in a way that prevents water vapour from condensing in them. In the event of particularly high steam levels in the room and the possibility of water droplets falling on the workstation, gutters or other devices should be installed to drain water from windows, skylights and sidelights. The glass in windows and skylights should be clean and allow a sufficient amount of light to pass through. Convenient and safe access should be provided for cleaning windows and skylights. Windows and skylights should be equipped with appropriate devices that eliminate excessive sunlight falling on workstations. Windows and skylights intended for airing rooms should be equipped with devices that allow them to be opened easily and safely from the floor level and to set the opening parts in the desired position. The GSM signal amplifier is discussed in detail in §192f sec. 6 item 4 and sec. 7 item 3 of the regulation of the Minister of Infrastructure. Social rooms must be separated from production, storage and quality control rooms. Toilets and washrooms do not have direct connections with production, storage and quality control rooms. Lighting, temperature, humidity and ventilation should be adequate and should not have a direct or indirect negative impact on medicinal products during their production and storage and on the proper functioning of devices. Social facilities for 10 people should have a minimum area of 8 m² (the regulation does not use the name “social room” but only “room for rest” or “dining room” or “hygienic and sanitary room”), and there may not be less than 1.1 m² per person; the height of the room may not be less than 2.5 m, unless it is a space in the basement, cellar or attic – then the lowest permissible height is 2.2 m. The changing room complex should include washrooms, rooms with showers, if required by working conditions and employee health protection. The Regulation of the Minister of Health indicates the need to separate an independent production area with separate devices for conducting the process and separate heating, ventilation and air conditioning systems, and it may be advisable to separate some installations from those used in other areas.
In order to limit access to the computerized system only to authorized persons, physical or logical security measures are introduced. Appropriate methods of preventing unauthorized entry into the system may include keys, access cards, personal codes with passwords, biometric data, limited access to computer equipment and data storage locations. If it cannot be ruled out that system failures or damages may cause permanent data loss, a copying system is used, ensuring permanent data archiving. For the computerized systems used, procedures should be developed and implemented to ensure appropriate data protection. Application software installed on a specific platform or computer equipment, providing specific functionality (applications), are validated, and the IT infrastructure (hardware and software, such as network software and operating systems, enabling the operation of applications) is qualified. In the context of internal cameras, it should be emphasized that facilities should be designed in such a way that it is possible to observe production activities from outside the A and B class areas (e.g. by providing windows or remote cameras with a full view of the area and processes to enable observation and supervision without having to enter the A and B classes). This requirement should be taken into account when designing new facilities or when modernizing existing facilities. The requirements for warehouses are discussed in detail in Annexes 2, 3 and 6 to the Regulation of the Minister of Health. The same Regulation contains a definition of Quality Control, detailed regulations regarding the R&D department, the technical department and maintenance, as well as requirements regarding the production process.
Summary
This article contains only the most important regulations concerning the procedure for applying for a permit to manufacture or import medicinal products and the requirements imposed on drug manufacturers in the production process. However, it should be remembered that the flagship legal acts in this area are: the Act of 6 September 2001 – Pharmaceutical Law; subsidiarily, the Code of Administrative Procedure; the regulation of the Minister of Health of 9 November 2015 on the requirements of Good Manufacturing Practice; the regulation of the Minister of Labour and Social Policy of 26 September 1997 on general occupational health and safety regulations, as well as the regulation of the Minister of Infrastructure of 12 April 2002 on the technical conditions that buildings and their location should meet. The article contains a description of the regulations of Polish law, but it should be remembered that the manufacturer is also obliged to comply with the standards of international law in this area – including: such European Union legal acts as: 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; Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, and the standards contained in a number of guidelines issued on the basis of these directives.