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Chief Pharmaceutical Inspectorate

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Controlled substances

The issuance of approvals for import or intra-Community acquisition of narcotic drugs or psychotropic substances and approvals for export or intra-Community acquisition of narcotic drugs or psychotropic substances.


Approvals for the import or intra-Community acquisition of narcotic drugs or psychotropic substances and approvals for the export or intra-Community acquisition of narcotic drugs or psychotropic substances are issued based on the REGULATION OF THE MINISTER OF HEALTH of 16 March 2017 on Detailed Conditions and Mode of Issuing Approvals and Documents Necessary for Import, Export, intra-Community Acquisition or intra-Community Supply of Narcotic Drugs, Psychotropic Substances, or Category 1 Precursors (Journal of Laws 2017.686).
List of required documents:

1. APPLICATION
a. An application for the approval for the import or intra-Community acquisition of narcotic drugs or psychotropic substances, hereinafter referred to as “the approval for import” should contain:

  • the name and exact address of the entity applying for the approval for import and the address of the place of business if different from the applicant’s address;
  • international non-proprietary name; if the application concerns formulations, provide the international non-proprietary name and the brand name;
  • a description of the narcotic drug or psychotropic substance which are to be imported or be subject to intra-Community acquisition, specifying the amount of the narcotic drug or psychotropic substance and the content of the pure narcotic drug or psychotropic substance expressed in grams;

NOTE! If the application concerns formulations, specify the pharmaceutical form, quantity, dose, and active substance content of the narcotic drug or psychotropic substance expressed in grams.

If the application concerns opium, specify also its grade and morphine content.

  •  the name and exact address of the consignor and the country of export or intra-Community supply;
  • specification of the purpose for which the narcotic drug or psychotropic substance are to be imported or be subject to intra-Community acquisition;
  • date, signature, and name and surname of the applicant or a representative authorised  to handle the applicant’s affairs.

b. An application for the approval for the export or intra-Community supply of narcotic drugs or psychotropic substances, hereinafter referred to as “the approval for export” should contain:

  • the name and exact address of the entity applying for the approval for export and the address of the place of business if different from the applicant’s address;
  • international non-proprietary name; if the application concerns formulations, provide the international non-proprietary name and the brand name;
  • a description of the narcotic drug or psychotropic substance which are to be exported or be subject to intra-Community supply, specifying the amount of the narcotic drug or psychotropic substance and the content of the pure narcotic drug or psychotropic substance expressed in grams; if the application concerns formulations, specify the pharmaceutical form, quantity, dose, and active substance content of the narcotic drug or psychotropic substance expressed in grams; if the application concerns opium, specify also its grade and morphine content.
  • the name and exact address of the consignee and the country of import or acquisition;
  • specification of the purpose for which the narcotic drug or psychotropic substance are to be exported or be subject to intra-Community supply;
  • date, signature, and name and surname of the applicant or a representative authorised  to handle the applicant’s affairs.

The application for export should be enclosed with the following documents:

  • the approval for import or the approval for intra-Community acquisition issued by competent authorities of the country of import or provide access to the approval by electronic means if the approval for import or the approval for intra-Community acquisition are issued in electronic form;

NOTE! For an approval for the export of a substance uncontrolled in the country of import, attach a document issued by a competent authority of the country of import confirming that the substances are not controlled in that country.
 

  • The application, together with the required documents, is to be sent to:

Główny Inspektorat Farmaceutyczny
ul. Senatorska12
00-082 Warszawa


2. FORM AS A WORD FILE

The filled-in attachment (files for download can be found in the materials to the article: Import; Export) in electronic form is to be sent to: gif@gif.gov.pl

Waiting time:

Pursuant to the Administrative Procedure Code, the Chief Pharmaceutical Inspector issues an approval or refusal of approval no later than within a month, as counted from the day of receiving the application (in paper form) at the mailroom of the Chief Pharmaceutical Inspector; if the application is incomplete, the date of issuing the approval may be postponed.

Powers of attorney:

If the business entity is represented by another person than the one specified in the National Court Register (KRS), provide a power of attorney containing:

  • name and surname and identity card number of the person(s) to whom the power of attorney is granted;
  • scope of the power of attorney (e.g. detailed description of activities the power of attorney concerns, including the filing of the application for the approval for the import/export and the collection of the approval, etc.);
  • date of granting the power of attorney;
  • signature of the person authorised to represent the entity entered in the National Court Register or the entrepreneur.

The power of attorney should be drafted in Polish or translated by a certified legal translator (sworn translator).

The power of attorney (original or copy certified by a notary) is to be submitted to the case file, i.e. attached to the application for the approval, and a separate stamp duty is to be paid (compare Article 1(1)(2) in relation to Article 6(1)(6) of the Stamp Duty Act of 16 November 2006 (Journal of Laws 2019.1000, as amended) and the Announcement of the Chief Pharmaceutical Inspectorate number 3 of 22 September 2009 on the principles of issuing documents produced in the Chief Pharmaceutical Inspectorate and fees paid on account of a power of attorney granted).

To the power of attorney, attach an extract from the National Court Register (KRS) indicating the authorisation to represent the company by the persons granting the power of attorney.

Type and method of making payments:

a. the fee for filing the application for the approval – PLN 100 (per every application filed) is to be paid to the account of the Chief Pharmaceutical Inspectorate – Narodowy Bank Polski, branch in Warsaw, number: 30 1010 1010 0056 2722 3100 0000;

b. the fee for filing the power of attorney – PLN 17 is to be paid at the cash office of the Borough Council of Śródmieście of the capital city of Warsaw, ul. Nowogrodzka 43, 00-691 Warszawa, or by bank transfer to the bank account number:

Warsaw City Hall
Tax Service Center
21 1030 1508 0000 0005 5000 0070 *


* Please be advised that from January 1, 2020, there is one bank account in the Capital City of Warsaw to which payments must be made for stamp duty.

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