Communique on the Import Inspection of Substances Subject to the Special Permission of the Ministry of Health

(PRODUCT SAFETY AND INSPECTION: 2014/4)

Purpose

ARTICLE 1 - (1) The purpose of this Communique is to regulate the procedures and principles concerning the conformity inspection in terms of human health and safety in the import of the substances and preparations listed in Annex-1 that are subject to the special permission of the Ministry of Health.

Scope

ARTICLE 2 - (1) This Communique covers the procedures and principles concerning the import of the substances and preparations listed in Annex-1 that are subject to the Release for Free Circulation Regime, the Inward Processing Regime, the Processing under Customs Control Regime and the Temporary Importation Regime.

Basis

ARTICLE 3 - (1) This Communique has been prepared on the basis of Article 4 of the Decision on the Technical Regulations Regime put into force by the Council of Ministers Decision No. 2013/4284 dated 28/1/2013.

Import inspection and certification

ARTICLE 4 - (1) The import of the substances and preparations listed in Annex-1 is carried out in accordance with the Law No. 2313 on the Control of Narcotic Substances dated 12/6/1933, the 1961 Single Convention on Narcotic Drugs, the 1971 Convention on Psychotropic Substances, the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, and the provisions of national legislation.

(2) The conformity of the substances and preparations listed in Annex-1 in terms of human health and safety is certified by the Ministry of Health with the Control Certificate in Annex-2.

(3) The Control Certificate is submitted by the importer or its representative to the relevant customs administration at the time of registration of the declaration within the scope of the Release for Free Circulation Regime, the Inward Processing Regime, the Processing under Customs Control Regime and the Temporary Importation Regime.

(4) The validity period of the Control Certificate is six months.

Application

ARTICLE 5 - (1) In order to obtain the Control Certificate, an application is made to the Ministry of Health (Turkish Medicines and Medical Devices Agency) before importation, together with the following documents:

Application petition,
Control Certificate form (3 copies),
Proforma invoice or invoice (3 copies),
Certificate of analysis.

(2) In the import of substances offered directly to the consumer, the following information must, where necessary, be presented to the Ministry of Health.

Trade name and address of the importing company,
Date of manufacture, storage conditions, serial number, content, instructions for use and characteristics of the goods,
Expiry date for goods with a shelf life,
Purpose of use and daily dose.

Licence specific to the import of substances subject to control

ARTICLE 6 - (1) In the import of the substances and preparations listed in Annex-1, the Licence Specific to the Import of Substances Subject to Control, with a validity period of six months, issued by the Ministry of Health in accordance with the legislation specified in the first paragraph of Article 4 and the Regulation on Chemical Substances Subject to Control published in the Official Gazette No. 25494 dated 16/6/2004, is required. The importer or its representative is obliged to send to the Ministry of Health (Turkish Medicines and Medical Devices Agency), within fifteen days at the latest after the import is realized, the customs-approved copy D of the Licence Specific to the Import of Substances Subject to Control and a copy of the relevant customs declaration. A copy of the same licence must accompany the goods.

(2) In the import of chemical substances that are listed in Annex-1 and fall within the scope of the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, brought into the customs territory of Turkey by the distributor company with the Licence Specific to the Import of Substances Subject to Control issued by the Ministry of Health but whose relevant customs procedures have not been completed, the Registration Certificate for Use at Customs Administrations in the Actual Import of Chemical Substances Subject to Control, valid for one year and issued by the Ministry of Health, is required. The importer or its representative is obliged to submit to the Ministry of Health (Turkish Medicines and Medical Devices Agency), within fifteen days at the latest after the import is realized, the original of the customs-approved document, a copy of the relevant customs declaration, the invoice, and the document issued by the distributor company to the importing company indicating under which licence the import was carried out.

Customs procedures

ARTICLE 7 - (1) In the import of the products listed in Annex-1, by the customs administrations;

the Control Certificate issued by the Ministry of Health is required at the time of registration of the customs declaration; copy D of the Licence Specific to the Import of Substances Subject to Control specified in the first paragraph of Article 6 is approved.
the Registration Certificate for Use at Customs Administrations in the Actual Import of Chemical Substances Subject to Control specified in the second paragraph of Article 6 is approved.

(2) In the procedures to be carried out by the relevant customs administration concerning the documents specified in subparagraphs (a) and (b) of the first paragraph, the declaration of the importer or its representative is taken as a basis. If it is determined that a false or misleading declaration has been made, the provisions of Article 8 are applied.

Sanctions

ARTICLE 8 - (1) For those who act contrary to this Communique and those who make false and misleading declarations, who use or present forged documents or who falsify documents, the Law No. 4703 on the Preparation and Implementation of Technical Legislation on Products dated 29/6/2001; the Customs Law No. 4458 dated 27/10/1999; the relevant provisions of the Decision on the Technical Regulations Regime No. 2013/4284, and other relevant legislation are applied.

Data notification

ARTICLE 9 - (1) Information and documents concerning the import of the products covered by this Communique are transmitted by the Ministry of Customs and Trade to the Ministry of Health in accordance with the needs to be determined by the Ministry of Health.

Measures concerning implementation

ARTICLE 10 - (1) The General Directorate of Product Safety and Inspection of the Ministry of Economy is authorized to take measures and make arrangements concerning the implementation of the matters set out in this Communique.

Repealed communique

ARTICLE 11 - (1) The Communique on the Import Inspection of Substances Subject to the Special Permission of the Ministry of Health (Product Safety and Inspection: 2013/4) published in the second repeated Official Gazette No. 28513 dated 30/12/2012 has been repealed.

Transitional period

PROVISIONAL ARTICLE 1 - (1) The import of products for which a transport document was issued for export purposes in the country of dispatch, or which were presented to the customs administrations in accordance with customs legislation, before the date this Communique entered into force, is subject to the provisions of the Communique on the Import Inspection of Substances Subject to the Special Permission of the Ministry of Health (Product Safety and Inspection: 2013/4) for a period of 45 days from the date this Communique entered into force. However, the more favourable provisions of this Communique apply to the said procedures.

(2) The control certificates obtained within the scope of the Communique on the Import Inspection of Substances Subject to the Special Permission of the Ministry of Health (Product Safety and Inspection: 2013/4) are valid from the date they were obtained for the period specified in the said Communique.

Entry into force

ARTICLE 12 - (1) This Communique enters into force on 1/1/2014.

Execution

ARTICLE 13 - (1) The provisions of this Communique are executed by the Minister of Economy.