Procedures for Registering and Licensing Operators

Issued pursuant to
Section 6 of the law On Precursors, and Section 14,
Paragraph two of the Freedom to Provide Services Law

1. This Regulation prescribes the procedures for registering and licensing operators who participate in the placing on the market of precursors (hereinafter - the operator).

2. In order to receive a special permit (licence) for operation with first category precursors (hereinafter - the special permit (licence)), the operator shall submit an application to the State Agency of Medicines. The application shall indicate the information in accordance with Article 5 of the Commission Regulation (EC) No 1277/2005 of 27 July 2005 laying down implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and for Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors (hereinafter - Regulation No 1277/2005).

3. The State Agency of Medicines shall evaluate the submitted data and documents, ascertain that the application for the receipt of the special permit (licence) complies with the conditions referred to in Paragraph 2 of this Regulation, and after results of an inspection conducted by the Health Inspectorate at the relevant site take a decision, in accordance with the procedures laid down in the Administrative Procedure Law, to issue the special permit (licence) for an indefinite period of time or to refuse to issue the special permit (licence) if the requirements referred to in laws and regulations regarding placing on the market of precursors have not been complied with.

4. In order to ascertain that the premises of the operator are suitable for the amount of work to be performed, as well as that the laws and regulations governing placing on the market of precursors are complied with, officials of the Health Inspectorate shall, prior to issuance of the special permit (licence) and within three to six months after re-registration of the special permit (licence) due to change of the premises (address), conduct an inspection at the relevant site.

5. The State Agency of Medicines shall ensure that the following information on the special permits (licences) is publicly available on its website (http://www.zva.gov.lv):

5.1. the data on the owner of the special permit (licence) (given name, surname, personal identity number of a natural person, name, registration number, legal address of a legal person);

5.2. the given name, surname, telephone and fax number of the responsible person determined in accordance with Chapter II of the Regulation No 1227/2005;

5.3. the number of the special permit (licence);

5.4. the date of the issuance of the special permit (licence).

6. In order to receive a registration card of the operator for operation with second and third category precursors (hereinafter - the registration card), except for the cases when registration is not required in accordance with Article 14 of Regulation No 1227/2005 and Section 4 of the law On Precursors, the operator shall submit an application to the State Agency of Medicines. The following information shall be indicated in the application:

6.1. the data on the applicant (given name, surname, personal identity number of a natural person, name, registration number, legal address of a legal person);

6.2. the intended activities with precursors;

6.3. the names of the precursors with which activities are intended;

6.4. the address of the storage of precursors;

6.5. the data of the responsible official (given name, surname, personal identity number) and his or her contact details (telephone and fax numbers, electronic mail address).

7. The State Agency of Medicines shall ascertain that the application for the receipt of the registration card complies with the conditions referred to in Paragraph 6 of this Regulation, evaluate the submitted data and documents and, in accordance with the procedures laid down in the Administrative Procedure Law, take a decision to issue the registration card for an indefinite period of time or to refuse to issue the registration card if the requirements referred to in laws and regulations regarding placing on the market of precursors have not been complied with.

8. The State Agency of Medicines shall ensure that the following information on the registration cards is publicly available on its website (http://www.zva.gov.lv):

8.1. the data on the owner of the registration card (given name, surname, personal identity number of a natural person, name, registration number, legal address of a legal person);

8.2. the given name, surname, telephone and fax number of the responsible person;

8.3. the number of the registration card;

8.4. the date of the issuance of the registration card.

9. An owner of the special permit (licence) and the registration card shall have the following obligations:

9.1. to provide the State Agency of Medicines with the information specified in the laws and regulations regarding placing on the market of precursors, including to inform of any changes related to the information to be indicated in the applications referred to in Paragraphs 2 and 6 of this Regulation within 10 working days;

9.2. to eliminate any deficiencies which were the reason for the suspension of the operation of the special permit (licence) or the registration card, and, within 30 days prior to the expiry of the term of suspension of the operation of the special permit (licence) or the registration card specified in the decision which has been referred to in Paragraph 11 of this Regulation, submit an application to the State Agency of Medicines for the renewal of the operation of the special permit (licence) or the registration card;

9.3. to submit, prior to the termination of the operation, an application to the State Agency of Medicines for the revocation of the special permit (licence) or the registration card due to the termination of the operation of the placing on the market of precursors by specifying the term of termination of the operation, and hand over the special permit (licence) or the registration card to the State Agency of Medicines on the next working day after the expiry of the term of operation.

10. The Health Inspectorate shall, within three working days after detection of a violation, provide proposals in writing to the State Agency of Medicines for the suspension or revocation of the special permit (licence) or the registration card, if during regular control of the placing on the market of precursors significant violations of the laws and regulations governing placing on the market of precursors have been found or the deficiencies established in the previous inspection have not been eliminated.

11. The State Agency of Medicines shall take a decision to suspend the operation of the special permit (licence) or the registration card for a period of up to six months if:

11.1. the owner of the special permit (licence) or the registration card has failed to submit data and documents to the State Agency of Medicines on any changes related to the information to be indicated in the applications referred to in Paragraphs 2 and 6 of this Regulation;

11.2. violations of the laws and regulations governing placing on the market of precursors have been established which according to the degree of severity may serve as a reason for the suspension of the operation of the special permit (licence) or the registration card.

12. The State Agency of Medicines shall take a decision to revoke the special permit (licence) or the registration card if:

12.1. an application has been received from the owner of the special permit (licence) or the registration card for the revocation of the special permit (licence) or the registration card due to the termination of the operation of the placing on the market of precursors;

12.2. it has been found that the operator has provided false information on the basis of which the decision was made to issue the special permit (licence) or the registration card.

13. The State Agency of Medicines shall repeal the decision to suspend the operation of the special permit (licence) or the registration card if a report has been received from the Health Inspectorate that the deficiencies which served as a reason for the suspension of the operation of the special permit (licence) or the registration card have been eliminated within the specified period of time.

14. The special permit (licence) or the registration card shall be revoked if the deficiencies which served as a reason for the suspension of the operation of the special permit (licence) or the registration card have not been eliminated within the specified period of time, and the owner of the special permit (licence) or the registration card has failed to submit the application referred to in Sub-paragraph 9.2 of this Regulation.

15. The State Agency of Medicines shall, within three days, notify the operator and the Health Inspectorate of the decision referred to in Paragraphs 11 and 12 of this Regulation, as well as update the information on the special permits (licences) and registration cards on the website of the State Agency of Medicines (http://www.zva.gov.lv).

16. The special permits (licences) and registration cards which the State Agency of Medicines has issued until the day of coming into force of this Regulation shall be valid until the end of the validity term indicated therein.

Prime Minister, Minister for Regional Development and
Local Government Affairs V. Dombrovskis

Minister for Health J. Bārzdiņš

Translation © 2018 Valsts valodas centrs (State Language Centre)