CHAPTER 6
Registration of Preparation

Section 40 A licensee to produce or import psychotropic substances in Schedule III or Schedule IV who wishes to produce or import any preparation containing the aforesaid psychotropic substances must first apply to the competent official for registration of such preparation and after having received a certificate of registration of the preparation, he may then produce or import such preparation.

The application for registration of preparation and the granting of a certificate of registration of preparation shall be in accordance with the rules, procedure and conditions as prescribed in the Ministerial Regulations.
The provisions of paragraph one shall not apply to a licensee to produce or import samples of authorized preparation; provided that he complies with the rules, procedure and conditions as prescribed in the Ministerial Regulations.

Section 41 The application for registration of a preparation under Section 40, must contain the following particulars:
(1)the name of the preparation;
(2)the name and quantity of ingredients which are composition of the preparation;
(3)the content;
(4)the method of analyzing the standard of composition of the preparation in case of applying a method which is not in the pharmacopoeia specified and notified by the Minister under the law on drugs;
(5)the label;
(6)the accompanying leaflet (if any);
(7)the name of its producer and the country where the place of production is located; and
(8)other items as prescribed in the Ministerial Regulations.

Section 42 An amendment of any particular of a registered preparation may be made only after having received a written permission from the competent official.

The application for amendment of a particular and the permission to amend a particular of a registered preparation shall be in accordance with the rules, procedure and conditions as prescribed in the Ministerial Regulations.

Section 43 The competent official shall not accept a preparation for registration in the case where he, with the approval of the Board, is of the opinion that:

(1)the application for registration of the preparation is not in accordance with Section 41 or with the Ministerial Regulations issued under Section 40;
(2)the preparation under the application for registration has unreliable properties or may be unsafe to the users;
(3)the name of the preparation under the application for registration is boastful, impolite, or my be misleading; or
(4)the preparation under the application for registration is a fake psychotropic substance under Section 37 or is a preparation which has been revoked by the Minister under Section 46.

The order refusing to accept the preparation for registration by the competent official shall be final.

Section 44 The provisions of Section 43 shall apply mutatis mutandis to the amendment of a particular of registered preparation.

Section 45 A certificate of registration of preparation shall be valid for five years from the date of issue. If a person receiving a certificate wishes to renew it, he must file an application before its expiration and after having filed it, he may continue his business until there is an order refusing to renew it.

The application for and the renewal of a certificate of registration of preparation shall be in accordance with the rules, procedure and conditions prescribed in the Ministerial Regulations.

In the case where the applicant has received the order refusing to renew a certificate, the provisions of Section 22 shall apply mutatis mutandis.

Section 46 If the Board is of the opinion that any registered preparation does not contain properties as registered or may be unsafe to the users or is a fake psychotropic substance or uses a name different from that which has been registered, the Board shall advise the Minister who shall have the power to revoke the registration of such preparation by issuing a Notification in the Government Gazette.

The decision of the Minister shall be final.

Section 47 In the case where a certificate of registration of preparation is lost or materially damaged the licensee shall inform the competent official of it and file an application for a substitute of certificate of the registration of preparation within fifteen days from the date of the knowledge of such lose of damage.
The application for and the issue of a substitute of certificate of registration of preparation shall be in accordance with the rules, procedure and conditions prescribed in the Ministerial Regulations.

CHAPTER 7
Advertisement

Section 48 A person shall not advertise the psychotropic substances for commercial purpose unless
(1)such advertisement is made directly to a medical practitioner, first-class practitioner in the branch of dentistry pharmacist or first-class veterinarian or
(2)it is a label or accompanying leaflet for a psychotropic substance on its container or package.

CHAPTER 8
Competent officials

Section 49 In the performance of duties, a competent official has the power to enter a place of production, place of sale, place of importation, or storage of psychotropic substances during office hours for inspection so as to ensure the execution in accordance with this Act and the power to take an appropriate quantity of psychotropic substances as samples for examination, or may in the case where there is reasonable ground to suspect that an offence under this Act has been committed, seize or attach the psychotropic substances relating to the offence including the containers or packages thereof and relevant documents for the purpose of instituting prosecution.

In the performance of duties of the competent official under paragraph one, the licensee and all persons having the duties in connection with the production, sale importation or storage of psychotropic substances in the place of sale, place of importation, or storage shall provide him with appropriate facilities.

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* As amended by the Narcotics Act (No.2) B.E.2528 (1985), (No.3) B.E.2530 (1987), (No.4) B.E.2543 (2000)

(1) As amended by the Narcotics Act (No.4) B.E.2543, published in the Government Gazette Vol. 117, Part 111A, dated 29th November B.E.2543, (No.5) B.E.2545, published in the Government Gazette, Vol. 119 Part 96A, dated 30 September B.E.2545

(2) Published in the Government Gazette Vol.96, Part 63, dated 27th April B.E.2522 (1979)

(3) Repealed by section 3 of the narcotics Act (No.2) B.E.2528 (1985), published in the Government Gazette Vol.102, Part 154, dated 24 October B.E.2528 (1985)

(4) Repealed and Replaced by section 4 of the Narcotics Act (No.2) B.E.2528 (1985)

(5) see the Notification of the Ministry of Public Health No.135 (B.E.2539) specifying names and categories of narcotics according to Narcotics Act B.E.2522 (1979) amended by Narcotics Act No.150 (B.E.2541), No.154 (B.E.2542), No.158 (B.E.2542) and No.170 (B.E.2544)

(6) Repealed and Replaced by section 3 of the Narcotics Act (No.3) B.E.2530 (1987), published in the Government Gazette Vol.104, Part 269, dated 28th December B.E.2530 (1987)

(7) Added by section 4 of the Narcotics Act (No.3) B.E.2530 (1987)

(8) Added by section 3 of the Narcotics Act (No.5) B.E.2530 (2002)

(9) Added by section 4 of the Narcotics Act (No.3) B.E.2530 (1987)

(10)- (11) Repealed and Replaced by section 4 of the Narcotics Act (No.5) B.E.2545 (2002)

(12)-(13) Added by section 5 of the Narcotics Act (No.5) B.E.2545 (2002)