Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B859: Traceability requirements, n.e.s. 

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 theDirector- 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 complementarymedicine may be made by –
(a) thePrincipal; or
(b) any other person acceptable to the Authority.
(4) Every application for the approval of a complementarymedicine 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 complementarymedicine in the smallest of each of the package formavailable for distribution to the public including the identification marks on such complementary complimentary medicinewhere appropriate, or if such package forms are not yet available , a sample in package , in which the applicant intends to make the complementarymedicineavailable 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 complementarymedicine 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) theappropriate fee, together with such additional fee as may be fixed by the authority for thepurpose of analysing such complimentary medicines .
(6) Every applicantshall, without delay inform the authority either before or after the approval of a complementary medicine-
(a) of any alteration from the information or particularsfurnished 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)(f) 

Measure also domestic

No 

Products affected by the measure.

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.

Description

All countries