Non-Tariff Measure

NTM classification
B82: Testing requirement 
Date when the measure came into force
11 September 2015 
Publication where the measure is specified
Statutory Instrument 97 of 2015 
Regulation where the measure is specified
Medicines and Allied Substances Control (Complementary Medicines) Regulations, 2015 
Country/Region applying the measure
Zimbabwe 
The rationale of the measure
Not stated in the regulations 
Coded list of objectives
X: For purposes n.e.s. 
Description of the measure
9. (1) For the purposes of subsection (6)(b) - 'finished product “in relation to a complementary medicine means complementary medicine which is wholly manufactured outside Zimbabwe and is imported into Zimbabwe and is ready for sale without having to be relabelled or repackaged.
(2) Any person who is required to make an application shall complete the appropriate form and shall furnish the Director- General, or some other person appointed by him or her , with such further information or particulars as may be required.
(3) An application for the approval of a complementary medicine may be made by –
(a) the Principal; or
(b) any other person acceptable to the Authority.
(4) Every application for the approval of a complementary medicine shall be submitted in form C.M.1 in duplicate.
(5) In addition to subsection (4) , such application shall be accompanied by the following –
(a ) a sample of the complementary medicine in the smallest of each of the package form available for distribution to the public including the identification marks on such complementary complimentary medicine where appropriate, or if such package forms are not yet available , a sample in package , in which the applicant intends to make the complementary medicine available for distribution to the public; and (b) detailed information of all package inserts which the applicant intends to use; and
(c) such samples of the complementary medicine or the raw materials thereof as the Authority may request for the analysis; and
(d) a single copy of any literature in support of the application. Provided that the Authority may require additional copies of such literature.
(e) a draft package insert or where there is no package insert, three labels or copies of the package and
(f) one copy of all records and batch data relating to a particular batch , where appropriate or possible, which shall include raw material analytical reports, master sheets relating to manufacture and packaging , in-process control records, final product analytical records and authorization for release , and any other relevant records; and
(g) the appropriate fee, together with such additional fee as may be fixed by the authority for the purpose of analysing such complimentary medicines.
(6) Every applicant shall, without delay inform the authority either before or after the approval of a complementary medicine-
(a) of any alteration from the information or particulars furnished by him or her in applying for approval in terms of subsections (4) and (5) ; and
(b) whether the complementary medicine is to be imported as a finished product , into or relabelled or repackaged or dealt with in any manner in Zimbabwe. 
Reference of the measure
Art 9 (5) (a) and (c) 
Measure also domestic
No 

Products affected by the measure.

Code Product Partial coverage Partial coverage indication Date in Date out
3004.90.10 Medicaments used in the management of chronic illnesses; approved by the secretary responsible for health No    
3004.90.20 Preparations containing a drug not categorised as prescription preparation No    
3004.90.90 Other No    
Description
Aromatherapeutic substances, Ayurvedic Medicines, Energy Substances or Medicines, Homeopathic Remedies, Nutritional Substance in pharmaceutical form, Traditional Chinese Medicines, Traditional Dutch Remedies, Unanni Tibb Medicines, Western Herbal Medicines and such other medicines or remedies as may be approved by the Authority 

Countries/Regions affected by the measure.

Inclusion/Exclusion Country Date in Date out
Inclusion Entire world    
Description
All countries