English
FrançaisNon-Tariff Measure
- NTM classification
- F69: Additional charges n.e.s.
- Date when the measure came into force
- 01 July 1991
- Publication where the measure is specified
- Statutory Instrument 150 of 1991
- Regulation where the measure is specified
- Medicines and Allied Substances Control (General) Regulations, 1991
- Country/Region applying the measure
- Zimbabwe
- The rationale of the measure
- Not specified in the regulations
- Coded list of objectives
- X: For purposes n.e.s.
- Description of the measure
- An application for the registration of a medicine may be made by –
(a) the principal: or
(b) any other person acceptable to the Authority.
2) Every application for the registration of a medicine shall be submitted in Form M.C. 8 and shall be accompanied by –
(a) a sample of the medicine in the smallest of each of the package forms available for distribution to the public including the identification marks on such medicine where appropriate; or
(b) if such package forms are not yet available a sample in a package, in which the applicant intends to make the medicine available for distribution to the public; and
(c) detailed information of all advertising material and package inserts which the applicant intends to use; and
(d) such samples of the medicine or the raw materials thereof as the Authority may request for analysis; and
(e) a single copy of any literature in support of the application:
Provided that the Authority may require additional copies of such literature; and
(f) twenty additional package inserts or, where there is no package inserts, twenty labels or copies of the package; and
(g) at least three copies of all records and batch data relating to a particular batch, 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
(h) the appropriate fee, together with such additional fee as may be fixed by the Authority for the purpose of analysing such medicine.
(3) Every applicant shall, without delay, inform the Authority either before or after the registration of a medicine –
(a) of any alteration from the information or particulars furnished by him in applying for registration in terms of subsection (2); and
(b) whether the medicine is to be imported as a finished product into, or relabelled or repackaged or dealt with in any other manner in Zimbabwe,
(4) For the purposes of paragraph (b) of subsection (3) –
“finished product”, in relation to a medicine, means a medicine which is wholly manufactured outside Zimbabwe and is imported into Zimbabwe and is ready for sale without have to be relabelled or repackaged.
(5) An application for the retention of the registration of a registered medicine shall be submitted to the Director-General, in duplicate in Form M.C. 9, and shall be accompanied by the appropriate fee which shall be payable on or before the 1st April annually. - Reference of the measure
- Art 35 (5)
- Measure also domestic
- Yes
Products affected by the measure.
| Code | Product | Partial coverage | Partial coverage indication | Date in | Date out |
|---|---|---|---|---|---|
| 3002.10.00 | Antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes | No | |||
| 3002.20.00 | Vaccines for human medicine | No | |||
| 3002.30.00 | Vaccines for veterinary medicine | No | |||
| 3002.90.00 | Other | No | |||
| 3003.10.00 | Containing penicillins or derivatives thereof, with a penicillinic acid structure, or streptomycin or their derivatives | No | |||
| 3003.20.00 | Containing other antibiotics | No | |||
| 3003.31.00 | Containing insulin | No | |||
| 3003.39.10 | Medicaments used in the management of chronic illnesses; approved by the secretary responsible for health | No | |||
| 3003.39.90 | Other | No | |||
| 3003.40.10 | Medicaments used in the management of chronic illnesses; approved by the secretary responsible for health | No | |||
| 3003.40.90 | Other | No | |||
| 3003.90.10 | Medicaments used in the management of chronic illnesses; approved by the secretary responsible for health | No | |||
| 3003.90.90 | Other | No | |||
| 3004.10.00 | Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives | No | |||
| 3004.20.00 | Containing other antibiotics | No | |||
| 3004.31.00 | Containing insulin | No | |||
| 3004.32.00 | Containing corticosteroid hormones, their derivatives or structural analogues | No | |||
| 3004.39.10 | Medicaments used in the management of chronic illnesses; approved by the secretary responsible for health | No | |||
| 3004.39.90 | Other | No | |||
| 3004.40.10 | Medicaments used in the management of chronic illnesses; approved by the secretary responsible for health | No | |||
| 3004.40.90 | Other | No | |||
| 3004.50.00 | Other medicaments containing vitamins or other products of heading 29.36 | No | |||
| 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 | |||
| 2003.90.00 | Other | No | |||
| 2004.10.00 | Potatoes | No | |||
| 2004.90.00 | Other vegetables and mixtures of vegetables | No | |||
| 2005.10.00 | Homogenised vegetables | No | |||
| 2005.20.00 | Potatoes | No | |||
| 2005.40.00 | Peas (pisum sativum) | No | |||
| 2005.51.00 | Beans, shelled | No | |||
| 2005.59.00 | Other | No | |||
| 2005.60.00 | Asparagus | No | |||
| 2005.70.00 | Olives | No | |||
| 2005.80.00 | Sweet corn (zea mays var. saccharata) | No | |||
| 2005.91.00 | Bamboo shoots | No | |||
| 2005.99.00 | Other | No | |||
| 2006.00.00 | Vegetables, fruit, nuts, fruit- peel and other parts of plants, preserved by sugar (drained, glace or crystallised) | No | |||
| 2007.10.00 | Homogenised preparations | No | |||
| 2007.91.00 | Citrus fruit | No | |||
| 2007.99.00 | Other | No | |||
| 2008.11.00 | Ground nuts | No | |||
| 2008.19.00 | Other, including mixtures | No | |||
| 2008.20.00 | Pineapples | No | |||
| 2008.30.00 | Citrus fruit | No | |||
| 2008.40.00 | Pears | No | |||
| 2008.50.00 | Apricots | No | |||
| 2008.60.00 | Cherries | No | |||
| 2008.70.00 | Peaches, including nectarines | No | |||
| 2008.80.00 | Strawberries | No | |||
| 2008.91.00 | Palm hearts | No | |||
| 2008.97.00 | Mixtures | No | |||
| 2008.99.00 | Other | No |
- Description
- All medicines except for substances controlled by the Hazardous Substances and Articles Act [Chapter 15:05]
Countries/Regions affected by the measure.
| Inclusion/Exclusion | Country | Date in | Date out |
|---|---|---|---|
| Inclusion | Entire world |
- Description
- All countries
