Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B14: Authorization requirements for importing certain products 

Date when the measure came into force

01 July 2008 

Publication where the measure is specified

Statutory Instrument 57 of 2008 

Regulation where the measure is specified

Medicines and Allied Substances Control (Import and Export of Medicines) Regulations, 2008. 

Country/Region applying the measure

Zimbabwe 

The rationale of the measure

These regulations shall apply to all medicines other than—
(a) those controlled in terms of the Dangerous Drugs Act [Chapter 15:02]; and
(b) psychotropic substances controlled in terms of the Medicines and Allied Substances
Control (General) Regulations, 1991; and
(c) medicines imported in terms of section 75 of the Act for a named person; and
(d) medicines imported by an individual for personal use. 

Coded list of objectives

X: For purposes n.e.s. 

Description of the measure

4.(1) Subject to section 13, no person shall import into or export from Zimbabwe any registered medicine otherwise than in accordance with the terms and conditions of a permit issued by the Authority.
5.(1) An application for the issue of a permit shall be made to the Director-General—
(a) in the case of an application for an import permit, in Form I.E.2 and shall be
accompanied by the fee prescribed in the Second Schedule;
(2) An application for the issue of an import permit shall state, for each medicine to be
imported—
(a) the name and address of the importer; and
(b) the trade name or proprietary name of the medicine, if any; and
(c) the International Non-Proprietary Name (INN) or generic name of the medicine; and
(d) its strength; and
(e) the total quantity of the medicine; and
(f) name and address of the supplier; and
(g) the name and address of the manufacturer, if not the same as the supplier; and
(h) the Zimbabwean registration number; and
(i) the cost, insurance, freight (CIF) value of the consignment; and
(j) the port of entry.
(3) Every application for an import permit shall be accompanied by a copy of the proforma
invoice and proof of consent by the principal or his or duly authorized importer to import the
medicine to which the application relates. 

Reference of the measure

Art 4 (1), 5(1)(a), (2) and (3) 

Measure also domestic

Yes 

Products affected by the measure.

Description

These regulations apply to all medicines other than
(a)Psychotropic substances (Amphetamine, Dexamphetamine, Methamphetamine, Methylphenidate, Phencyclidine, Amobarbital, Cyclobarbital, Pentobarbital, Secobarbital, Amfepramone, Barbital, Ethinamate, Meprobamate, Methylphenobarbital, Phenobarbital, Pipradrol)

(b)Drugs controlled in terns of the Dangerous Drug Act ( coca leaves; “Indian hemp”, “bhang”, “camba”, “dagga”, “mbanje” or “intsangu”, resins obtained therefrom and all preparations of which such resins form the base; raw opium;1.Medicinal opium.
2. Any medicinal extract or tincture derived from the plant Cannabis sativa L. and any
preparation, not being a preparation capable of external use only, made from such
medicinal extract or tincture.
3. Morphine and its salts.
4. Cocaine (including synthetic cocaine) and ecgonine and their respective salts, and the
esters of ecgonine and their respective salts. (For the purposes of this Act, the expression
“ecgonine” means laevo-ecgonine and includes any derivatives of ecgonine from which it
may be recovered industrially.)
5. Any solution or dilution of morphine or cocaine or their salts in an inert substance,
whether liquid or solid, containing any proportion of morphine or cocaine, and any
preparation, admixture, extract or other substance (not being such a solution or dilution as
aforesaid) containing not less than one-fifth per centum of morphine or one-tenth per
centum of cocaine or of ecgonine.
6. Diacetylmorphine (commonly known as diamorphine or heroin) and the other esters of
morphine and their respective salts.
7. Dihydrohydroxycodeinone (also known as oxycodone);
Dihydrocodeinone (also known as hydrocodone);
Dihydromorphinone (also known as hydromorphone);
Acetyldihydrocodeinone;
Dihydromorphine;
their esters, and the salts of any of these substances and of their esters.
8. Morphine-N-oxide (commonly known as genomorphine) also the morphine-N-oxide
derivatives, and the other pentavalent nitrogen morphine derivatives. )

(c) Any medicines exempted from the operation of any or all of the provisions of the Medicines and Allied Substance Control Act
(d) The Regulations also excludes medicines imported by an individual for personal use. 

Countries/Regions affected by the measure.

Description

All countries