Chief Pharmaceutical Inspectorate

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

1. The manufacturing inspectors of the Chief Pharmaceutical Inspectorate (CPI) 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 the third country.

Note
Chief Pharmaceutical Inspectorate may request the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products about the status of the registration/changing of registration process.

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

• a registered importer of active substances has submitted an application for an inspection; whereby the active substances specified in the application are applied to manufacture a medicinal product destined for the Polish market;
• the manufacturer of the medicinal product who applies 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 the documents submitted in the application are incomplete, the applicant will be asked to provide additional information.

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 (recommended);
• details of the medicinal products (name, form, dose, marketing authorisation number if applicable) or information on the active substances (name) to be inspected;
• detailed information about the requested scope of inspection, e.g., with reference to manufacturing operations specified in the GMP certificate templates (medicinal product and/or active substances according to the document Compilation of Union procedures on inspections and exchange of information - Interpretation of the Union format for GMP certificate)
• 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, , 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.

If the inspection results confirm that the manufacturer or importer of the medicinal product meets the requirements of Good Manufacturing Practice, the Chief Pharmaceutical Inspector shall issue, within 90 days from the last day of completion of the inspection a certificate confirming compliance of the manufacturing conditions of the medicinal product with the requirements of Good Manufacturing Practice (GMP certificate).

If, as a result of the inspection, it is determined that the manufacturer of medicinal products does not comply with Good Manufacturing Practice requirements, the Chief Pharmaceutical Inspector will promptly enter such information into the European EudraGMDP database and revoke the certificate confirming compliance with Good Manufacturing Practice requirements, if the manufacturer or importer possesses that certificate.

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 – the fee for the power of attorney should be paid according to the information provided below: link.

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; if it is written in a language other than Polish, a translation into Polish must be attached to the document. The translation should be certified by a sworn translator (original or officially certified copy of the translation).

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 covering the costs of travel, accommodation, and the time spent by inspectors performing inspection activities.

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.. Before the expiration of this period, the applicant is obliged to contact the Chief Pharmaceutical Inspector or another competent authority of the European Union in order to submit a request for an another inspection. In the case of submitting a request to the GIF, the application should be sent 9-12 months before the expiration date of the GMP certificate.