CHAPTER 5
Narcotics of category III
Fake Narcotics, Narcotics differing from
Standards or Deteriorated Narcotics

Section 39 No person shall produce, dispose of, import or export the following narcotics of category III:

(1)fake narcotics under section 40;
(2)narcotics differing from the standards under section 41;
(3)deteriorated narcotics under section 42;
(4)narcotics, the medicinal formula of which are required to be registered but have not been registered under section 43;
(5)narcotics, the medicinal formula of which have been removed from the register by order of the Minister under section 46

Section 40 The following narcotics of category III or substances shall be regarded as fake narcotics:

(1)drugs or substances which show, by whatever manner, that they are narcotics of category III but in fact do not contain the narcotics of category III;
(2)narcotics of category III bearing the names of another narcotics or showing the expiry month and year, which is false;
(3)narcotics of category III bearing the name or mark of a producer, or the location of the place of production, which is false;
(4)narcotics of category III or narcotics specified in the Notification of the Minister under section 8 (1) or those complying with the registered medicinal formula of the narcotics of category III, which is false;
(5)narcotics of category III produced differently from the standards to the extent that the active ingredients are more than ten percent lower or higher than the quantity prescribed to be the minimum or maximum limit prescribed in the Notification of the Minister under section 8 (3) or prescribed in the registered medicinal formula of the narcotics of category III.

Section 41 The following narcotics of category III shall be regarded as narcotics differing from the standards:

(1)narcotics of category III produced differently from the standards to the extent that the active ingredients are more than ten percent lower or higher than the quantity prescribed to be the minimum or maximum limit prescribed in the Notification of the Minister under section 8 (3) or prescribed in the registered medicinal formula of the narcotics of category III;
(2)narcotics of category III produced with the purity or other characteristics essential to the quality of the active ingredients different from the limits prescribed in the Notification of the Minister under section 8 (3) or prescribed in the registered medicinal formula of the narcotics of category III.

Section 42 The following narcotics of category III shall be regarded as deteriorated narcotics:

(1)narcotics of category III which have expired as shown on the label registered in the medicinal formula;
(2)narcotics of category III which have denatured to the extent that it has the same characteristics as fake narcotics under section 40 or narcotics differing from the standards under Section 41.

CHAPTER 6

Registration of a Medicinal Formula of the Narcotics of Category III

⁽²⁷⁾Section 43 The license to produce or import narcotics of category III, who wishes to produce or import the said narcotics, shall apply to the competent official for the registration of the medicinal formula of the said narcotics; and upon receipt of a certificate of registration of the medicinal formula of narcotics, he may then produce or import the said narcotics into the Kingdom.

The application for the registration of the medicinal formula of the narcotics of category III and the issuance of the certificate of registration of the medicinal formula of the said narcotics shall be in accordance with the rules, procedure and conditions prescribed in the Ministerial Regulation. ⁽²⁸⁾In considering the issuance under paragraph one, the person who apply to register for a medical formula shall be responsible for expenses in analysis or accession of technical document in accordance with rules and procedure prescribed by the committee by publication in the Government Gazette.

⁽²⁹⁾Section 44 The licensee to produce or import narcotics of category III under section 43 may amend the particulars in the registration of the medicinal formula of the narcotics of Category III when he has obtained a written permission from the licensing authority.

The application for amending the particulars and the issuance of the written permission to amend the particulars in the registration of the medicinal formula of the narcotics of category III shall be in accordance with the rules, procedure and conditions prescribed in the Ministerial Regulation.

Section 45 A certificate of registration of the medicinal formula of the narcotics of category III shall be valid for five years from the date of issuance. If the person holding the certificate wishes to apply for its renewal, he shall file an application before the expiration of the term of the certificate; and after having filed the application, he may carry on his business until the licensing authority makes an order refusing to renew the certificate.

The application for the renewal of a certificate of registration of the medicinal formula of the narcotics of category III, and the permission of the renewal thereof shall be in accordance with the rules, procedure and conditions prescribed in the Ministerial Regulation.

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(27) Repealed and Replaced by Section 8 of the Narcotics Act (No.3) B.E.2530 (1987)

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

(29) Repealed and Replaced by section 8 of the Narcotics Act (No.3) B.E.2530 (1987)