A person desirous of registering a traditional drug with the Board of Authority may do so in accordance with the stipulations.

A person who is permitted to register the traditional drug:-

(a) shall pay the prescribed registration fees;

(b) shall abide by the conditions relating to registration and shall also abide by the orders and directives issued by the Board of Authority;

(c) on the expiry of the tenure of registration, may extend it by paying the prescribed fees for extension of the term of registration.

If a person who has been permitted to register the traditional drug is found on investigation to have violated any condition relating to permission for registration or any order or directive issued by the Board of Authority the organization or person to whom the Board of Authority has assigned responsibility may revoke the registration subject to a time limit or cancel it.

A person desirous of manufacturing a registered traditional drug shall apply for a licence to the Board of Authority in accordance with the stipulations.

A person who has obtained a licence shall:-

(a) pay the prescribed licence fees;

(b) abide by the conditions contained in the licence as well as the orders and directives issued by the Board of Authority;

(c) on expiry of the tenure of the licence pay the fees for extension of the tenure of the licence and extend the tenure of the same.

If a person who has obtained a licence is found on investigation to have violated any condition of the licence or any order or directive issued by the Board of Authority, the organization to which or the person to whom the Board of Authority has assigned responsibility may revoke the licence subject to a time limit or cancel it.

A person whose licence has been cancelled:-

(a) shall not apply for a new licence;

(b) may hand over or sell the traditional drugs in his possession which are determined by the Board of Authority as of standard quality to another person who has obtained a licence, within 60 days;

(c) with respect to traditional drugs in his possession, which are below standard quality shall dispose them of as directed by the Board of Authority.

No one shall manufacture the following traditional drug:-

(a) a traditional drug which has not been registered;

(b) a drug for which registration has been revoked subject to a time limit or cancelled;

(c) a traditional drug differing from standards;

(d) a traditional drug which is determined as unfit for use by the Ministry of Health by notification.

No one shall sell the following traditional drug:-

(a) a traditional drug which has not been registered;

(b) a traditional drug for which registration has been revoked subject to a time limit or cancelled;

(c) a deteriorated traditional drug;

(d) a traditional drug which is determined as unfit for use by the Ministry of Health by notification.

No one shall manufacture a traditional drug without a licence.

A person who has obtained a licence:-

(a) shall not fail to abide by any condition of the licence;

(b) shall not fail to abide by the orders and directives issued by the Ministry of Health, the Board of Authority, or the Department of Traditional Medicine.

Whoever violates any provision of section 27 or section 28 of this Law shall, on conviction, be punished with fine which may extend to kyats 30,000 or with imprisonment for a term which may extend to 3 years, or with both. In addition, the exhibits involved in the offence shall also be liable to be confiscated.

Whoever violates any provision of section 29 shall, on conviction:-

(a) if it is an offence relating to an unregistered traditional drug, be punished with fine which may extend to Kyats 30,000, or with imprisonment for a term which may extend to 3 years, or with both;

(b) if it is an offence relating to a registered traditional drug, be punished with fine which may extend to Kyats 10,000, or with imprisonment for a term which may extend to two years, or with both;

(c) the exhibits involved in the offence shall also be liable to be confiscated.

A person who, has obtained a licence and who violates any provision of section 30 shall, on conviction, be punished with fine which may extend to Kyats 5,000, or with imprisonment which may extend to one year, or with both.