Chief Pharmaceutical Inspectorate

An inspection at the premises of the manufacturer of a medicinal product or active substance in a third country may be carried out only in the following cases.

The manufacturing inspectors of the Chief Pharmaceutical Inspectorate shall carry out an inspection at the premises of the manufacturer of the medicinal product if the marketing authorisation holder has requested:

• to obtain a marketing authorisation;

• for a variation of a marketing authorisation for a change of manufacturing site in a third country;

• for the issuance of Certificates of Good Manufacturing Practice in the event that the medicinal product is imported into the territory of the Republic of Poland from a third country.

The first request of a party to carry out an inspection with a view to issuing a certificate constituting
a certificate confirming compliance with the requirements of Good Manufacturing Practice by the manufacturer of a given medicinal product, submitted in the framework of obtaining a marketing authorization, results in an inspection by GMP inspectors from the Inspectorate.

On the next application in the same case, Chief Pharmaceutical Inspectorate requests the Office
for Registration of Medicinal Products, Medical Devices and Biocidal Products to inform about the status of the registration process. An inspection may not be carried out where the administrative procedure for obtaining a marketing authorisation has been suspended at the request of a party or
for any other reason. In this case, the date of the inspection shall be set after consultation with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products prior to the granting of the marketing authorisation.

2. The GMP inspectors of the Chief Pharmaceutical Inspectorate shall inspect the manufacturer of the active substances if:

• a registered importer of active substances has submitted an application for an inspection;

• the manufacturer of the medicinal product who uses the active substance has requested
an inspection;

• the responsible entity, which has the mentioned manufacturer of the active substance in the registration dossier of the medicinal product, and the manufacturer conducts its activity on the territory of the Republic of Poland, has submitted an application for an inspection.

Paper or electronic documentation must be submitted or sent to the General Office of the Chief Pharmaceutical Inspectorate. The submitted documentation is subject to verification both in terms
of formal and substantive aspects.

If deficiencies are found, a request to supplement them is formulated, along with an indication of the legal basis. If the entrepreneur does not complete the formal deficiencies within the prescribed period, the application will remain without consideration – in accordance with Article 64 § 2 of the Act of 14 June 1960 - Code of Administrative Procedure.

In the event of difficulties in completing the deficiency in the application within the time limit specified in Article 64 § 2 of the Code of Civil Procedure, the party may apply to the authority with a request to suspend the proceedings. Pursuant to Article 98 of the Kpa, a public administration body may suspend proceedings if the party at whose request the proceedings were initiated so requests, and other parties do not object to it and it does not threaten the public interest.

After confirming the completeness of the documents, the Applicant is informed in writing about the exact date of the inspection and the costs associated with it.

The costs of this inspection are calculated in accordance with Articles 47b and 51 j of the Law of 6 September 2001. Pharmaceutical Law as well as the Regulation of the Minister of Health of 10 March 2015 on the amount and method of covering the costs of conducting an inspection at the manufacturer or importer of medicinal products by  GMP inspectors of the Chief Pharmaceutical Inspectorate or with the Regulation of the Minister of Health of 2 March 2015 on the amount and method of covering the costs of conducting inspections at the manufacturer, importer or distributor of active substances or at the manufacturer of excipients by GMP inspectors of the Chief Pharmaceutical Inspectorate.

The applicant is obliged to pay the amount of inspection costs indicated in the letter to the account of the Chief Pharmaceutical Inspectorate within 14 days from the date of receipt of the notification. Proof of payment should be sent immediately to the e-mail address indicated in the letter. However, proof of payment of the hotel fee and proof of purchase of air tickets must be provided no later than 30 days before the planned start of the inspection.

The application should include:

• the case in question (see information above);

• the exact name and address of the manufacturer and the place of manufacture;

• DUNS number of the manufacturing site;

• details of the medicinal products (name, form, dose, marketing authorisation number if applicable) or information on the active substances to be inspected;

• information whether all manufacturing processes are carried out in one place, i.e. whether there are no outsourcing of manufacturing stages (e.g. quality control tests) to external entities;

• whether an inspection by another competent authority of the European Union or MRA countries (Australia, Canada, Switzerland, New Zealand, Japan, USA, Switzerland, Israel, United Kingdom) has taken place at the manufacturing site in question.

In addition, the application should be signed by a person authorized to represent the entity
in accordance with applicable regulations or by a proxy acting on the basis of a power of attorney signed by the above-mentioned person.

The application shall be accompanied by:

• in the case of an inspection at the premises of the manufacturer of the medicinal product, a certified copy of the manufacturing authorisation issued by the competent authority in the country where the medicinal product is manufactured and a translation into Polish or English;

• a copy of the marketing authorisation for the medicinal product or confirmation of the submission to the Office for Registration of Medicinal Products for Medical Devices and Biocidal Products of
an application for a marketing authorisation, if applicable;

• Site Master File of the manufacturing site in English or Polish;

• original proof of payment, confirming the payment of stamp duty in the amount of PLN 51 (PLN 17 for one certificate, with the party receiving two certificates - one in Polish, the other in English, while an additional certificate in English is received by the manufacturer subject to inspection);

• proof of payment, confirming the payment of stamp duty from the submission of a power of attorney in the amount of PLN 17 from each power of attorney, if applicable.

Within 90 days of the inspection, counting from the last day of the inspection, the Chief Pharmaceutical Inspector issues a Certificate of Good Manufacturing Practice or a decision refusing to issue it.

• Cost of the planned inspection - calculated in accordance with Articles 47 b and 51 j of the Act of 6 September 2001. Pharmaceutical Law as well as the Regulation of the Minister of Health of 10 March 2015 on the amount and method of covering the costs of conducting an inspection at the manufacturer or importer of medicinal products by GMP inspectors of the Chief Pharmaceutical Inspectorate or with the Regulation of the Minister of Health of 2 March 2015 on the amount and method of covering the costs of conducting inspections at the manufacturer, importer or distributor of active substances or at the manufacturer of excipients by GMP inspectors of the Chief Pharmaceutical Inspectorate;

• Inspection cost is 900 PLN for every hour started by a single GMP inspector;

• The cost of the certificate - stamp duty in the amount of PLN 51 (PLN 17 for one certificate, with the party receiving two certificates - one in Polish, the other in English, while an additional certificate in English is received by the manufacturer subject to inspection);

• The cost of the power of attorney – stamp duty in the amount of PLN 17.

• Inspection fee - payment to the account of the Chief Pharmaceutical Inspectorate – NBP o/o in Warsaw No. 30 1010 1010 0056 2722 3100 0000;

• Cost of the certificate - stamp duty paid to the account of the City of Warsaw, Taxpayer Service Center No. 21 1030 1508 0000 0005 5000 0070

• Cost of power of attorney – stamp duty paid to the account of the City of Warsaw, Taxpayer Service Center No. 21 1030 1508 0000 0005 5000 0070.

In the case of representation of the entrepreneur by a proxy, a power of attorney document containing:

• Designation of the entrepreneur (the entrepreneur's name and the address of the registered office, respectively the KRS number and / or NIP).

• Name and surname, PESEL or other data uniquely identifying the person or persons authorized to act on behalf of the entrepreneur (data of the representative).

• The date of granting the power of attorney.

• The 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 an inspection, review of files, receipt of a certificate, etc.).

• Signature of the entrepreneur or person(s) authorized to make declarations of will on behalf of the entrepreneur (in accordance with the National Court Register).

The power of attorney should be submitted in Polish or translated by a sworn translator.

The power of attorney (the original or an officially certified copy of the power of attorney, the lawyer and legal advisor may themselves certify a copy of the power of attorney granted to them and copies of other documents showing their authorization) must be submitted to the case file, i.e. e.g. attach to the application for an inspection, together with proof of payment of stamp duty in the amount of PLN 17 (cf. Article 1 point 2 in conjunction with Article 6 paragraph 1 point 4 of the Act of 16 November 2006 on stamp duty).

The power of attorney should be accompanied by documentation confirming that the person(s) granting the power of attorney on behalf of the entrepreneur were entitled to do so on the date of granting the power of attorney (if it does not result from the register of entrepreneurs of the National Court Register).

• In accordance with Articles 47 b and 51 j of the Law of 6 September 2001. Pharmaceutical Law as well as the Regulation of the Minister of Health of 10 March 2015 on the amount and method of covering the costs of conducting inspections at the manufacturer or importer of medicinal products by inspectors for the manufacture of the Chief Pharmaceutical Inspectorate or with the Regulation of the Minister of Health of 2 March 2015 on the amount and method of covering the costs of conducting inspections at the manufacturer, importer or distributor of active substances or at the manufacturer of excipients by manufacturing inspectors of the Chief Pharmaceutical Inspectorate  The applicant is responsible for providing inspectors with hotel accommodation and for purchasing air tickets;

• In order to clarify any doubts regarding the organization of the inspection, the manufacturer contacts the designated Lead Inspector;

• The certificate is a confirmation of compliance of the manufacturing conditions with the requirements of Good Manufacturing Practice, found during the above-mentioned inspection. The certificate cannot be used to confirm GMP status after 3 years from the date of the last day of the inspection. After this period, the manufacturer is obliged to contact the Chief Pharmaceutical Inspector or other competent authority of a Member State of the European Union for another inspection.

GMP Inspection Department

Magdalena Śliczniak

Head of the Department for the Supervision of Active Substances 

Manufacturing Inspection Department

tel. 22 441 07 05