Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B81: Product registration/approval requirements 

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 

Measure also domestic

Yes 

Products affected by the measure.

Description

FIFTH SCHEDULE (Section 34)
PHARMACOLOGICAL CLASSIFICATION CATEGORIES OF MEDICINES
PART I
HUMAN CLASSIFICATION
1. Anaesthetics
1.1 General anaesthetics and medical gases
1.2 Local Anaesthetics
1.2.1 Injectable
1.2.2 Topical
1.3 Cholinesterase inhibitors and muscle relaxants used in anaesthesia
1.4 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
2. Analgesics and antipyretics
2.1 Single ingredient products
2.2 Compound products
2.3 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
3. Medicines used in rheumatism and gout
3.1 Nonsteroidal anti-inflammatory medicines
3.2 Medicines for gout
3.3 Special antirheumatic medicines
3.4 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
4. Narcotic analgesics/narcotic antagonists
4.1 Narcotic analgesics
4.2 Narcotic antagonists
5. Antihistamines
6. Antidotes
6.1 General
6.2 Specific
6.3 Medicines used in the treatment of addictions:
6.3.1. Alcohol
6.3.2. Nicotine
6.3.3. Narcotics
6.3.4 Psychotropic
6.3.5 Others
7. Anti – infective medicines
7.1 Penicillins
7.1.1 Non beta-lactamase resistant
7.1.2 Beta-lactamase resistant
7.2 Other antibacterials:
7.2.1. Aminoglycosides
7.2.2 Cephalosporins
7.2.3. Sulphonamides (including combinations with trimethoprim).
7.2.4. Tetracyclines
7.2.5. Others
7.3 Antituberculars
7.4 Antileprotics
7.5 Antimalarials
7.6 Antiprotozoals (other than antimalarials).
7.7 Anthelmintics
7.8 Antischistosomals
7.9 Antitrypanosomals
7.10 Leishmanicides
7.11 Antifilarials
7.12 Antifungals (systemic)
7.13 Antivirals
7.14 Urinary antiseptics
7.15 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
8. Antimigraine medicines
9. Antineoplastic and immunosuppressive medicines
9.1 Alkylating agents:
9.1.1 Nitrogen mustard
9.1.2. Alkyl sulphonates
9.1.3. Nitrosureas
9.1.4. Triazines
9.2 Antimetabolites
9.2.1 Folic acid analogues
9.2.2 Pyrimidine analogues
9.2.3 Purine analogues
9.3 Natural products and their derivatives:
9.3.1 Vinca alkaloids
9.3.2 Antibiotics
9.3.3 Enzymes
9.4 Miscellaneous cytotoxic agents
9.5 Hormones and hormone inhibitors
9.5.1 Hormones
9.5.2 Hormone inhibitors
9.6 Immunosupressive agents
9.7 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
10. Medicines affecting the blood
10.1 Anti-anaemia preparations:
10.1.1 Iron
10.1.2 Folates
10.1.3 Vitamin B12
10.1.4 Combinations
10.2 Anticoagulants
10.3 Anticoagulant antagonists
10.4 Haemostatics
10.5 Medicines modifying platelet function
10.6 Medicine altering blood viscosity
10.7 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
11. Blood products/blood substitutes
11.1 Plasma substitutes and expanders
11.2 Plasma fractions for specific uses
11.3 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
12. Cardiovascular medicines
12.1 Antianginal medicines
12.2 Antiarrhythmic medicines
12.3 Antihypertensive medicines
12.3.1 Vasodilators
12.3.2 Beta blockers
12.3.3 Centrally acting antihypertensives
12.3.4 Ganglion blockers
12.3.5 Others
12.4 Cardiac glycosides
12.5 Diuretics and antidiuretics:
12.5.1 Diuretics
12.5.2 Antidiuretics
12.6 Calcium antagonists
12.7 Sympathomimetic cardiac stimulants
12.8 Medicines modifying serum lipids
12.9 Other cardiovascular medicines
13. Central nervous system medicines
13.1 Anticonvulsants
13.2 Psychotherapeutic medicines
13.2.1 Antidepressants
13.2.2 Anxiolytics
13.2.3 Antipsychotics
13.3 Hypnotics
13.4 Antiparkinsonian medicines
13.5 Medicines for myaesthenia gravis
13.6 Muscle relaxants, centrally acting
13.7 CNS stimulants
13.8 Medicines improving cerebral blood flow or metabolism
13.9 Respiratory stimulants, centrally acting
13.10 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
14. Dermatological and topical preparations
14.1 Topical anti-infectives
14.1.1 Antibiotics
14.1.2 Sulphonamides
14.1.3 Antifungals
14.1.4 Antiseptics and disinfectants
14.1.5 Scabicides and pediculocides
14.2 Topical corticosteroids
14.2.1 Plain
14.2.2 Combinations
14.3 Topical antihistamines
14.7 Anti-dandruff preparations
14.8 Keratolytics
14.9 Topical cytotoxics
14.10 Sunscreen agents
14.11 Melanin stimulants
14.12 Melanin inhibitors
14.13 Astringents
14.14 Emollients
14.15 Rubefacients
14.16 Medicated dressings
14.17 Vaginal preparations
14.18 Heavy metal preparations
14.19 Others
15. Diagnostic agents
15.1 Miscellaneous
15.1.1 Serological
15.1.2 Skin tests
15.1.3 Blood grouping
15.1.4 Others
15.2 Radiocontrast media
15.3 Reagent strips and tablets
15.4 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
16. Gastrointestinal medicines
Antacids
Antiemetics
Antihaemorrhoidals
Antispasmodics
Laxatives
Lubricants and softeners
16.5.2 Stimulants
16.5.3 Bulking agents
16.5.4 Osmotic agents
16.5.5 Combinations
16.5.6 Others
16.6 Antidiarrhoeals
16.7 Gastric/peptic ulcer medicines
16.8 Gastrointestinal enzymes
16.8.1 Pancreatic enzymes
16.8.2 Other GI enzymes
16.9 Appetite depressants:
16.9.1 Centrally acting
16.9.2 Locally acting
16.10 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
17. Endocrine system medicines
17.1 Corticosteroids
17.2 Androgens
17.3 Oestrogens
17.4 Progestogens
17.5 Sex hormone combinations (excluding contraceptive preparations)
17.6 Insulins
17.7 Oral antidiabetic medicines
17.8 Thyroid hormones/inhibitors
17.8.1 Thyroid hormones
17.8.2 Thyroid inhibitors
17.9 Parathyroid hormones/inhibitors
17.9.1. Parathyroid hormones
17.9.2. Parathyroid inhibitors
17.10 Pituitary hormones/inhibitors
17.10.1 Pituitary hormones
17.10.2 Pituitary inhibitors
17.11 Trophic hormones
17.12 Hormone inhibitors (other than the above)
17.13 Fertility stimulants
17.14 Others
18. Immunologicals
18.1 Sera/immunoglobulins
18.1.1 Antitoxins
18.1.2 Antivenoms
18.1.3 Immune globulins
18.1.4 Others
18.2 Vaccines
18.3 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
19. Ophthalmic medicines
19.1 Anti- infective
19.1.1 Antibiotics
19.1.2 Sulphonamides
19.1.3 Antivirals
19.1.4. Antiseptic
19.1.5 Others
19.2 Corticosteroids
19.2.1 Without antibiotics
19.2.2 With antibiotics
19.3 Local anaesthetics
19.4 Miotics
19.5 Mydriatics
19.6 Diagnostics
19.7 Systemic
19.8 Contact lens preparations
19.9 Topical decongestants and anti- allergics
19.10 Others
20. Ear, nose, throat and mouth preparations
20.1 Ear:
20.1.1 Anti – infective
20.1.2 Anti – inflammatory
20.1.3 Analgesic
20.1.4 Wax removers
20.1.5 Others
20.2 Nose:
20.2.1 Anti – infective
20.2.2 Corticosteroid (plain and combination)
20.2.3 Antihistamines (plain and combination)
20.2.4 Other decongestants and anti-allergics
20.2.5 Cauterising preparations
20.2.6 Others
20.3 Throat and mouth
20.3.1 Special dental preparations
20.3.2 Mouth ulcer preparations
20.3.3. Local analgesics/anaesthetics (including tooth ache and teething preparations)
20.3.4 Antiseptic mouthwashes, gargles, sprays, paints etc.
20.3.5 Antiseptic lozenges
20.3.6 Others
20.4 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
21. Medicines used in obstetrics, gynaecology and urinary tract disorders
[amended by S.I. 199 of 1998 with effect from 7 August,1998.]
21.1 Labour and delivery
21.1.1 Pre-partum uterine contraction stimulants
21.1.2 Post–partum uterine contraction stimulants
21.1.3 Uterine contraction inhibitors
21.2 Hormonal contraceptive:
21.2.1 Combined oral contraceptives
21.2.2 Progesterone – only oral contraceptives
21.2.3 Injectables
21.2.4 Others
21.3 Spermicides
21.4 Intrauterine devices
21.5 Barrier devices
21.6 Prostaglandins [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
21.7 Urinary tract disorders [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
21.8 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
22 Medicines acting on the respiratory tract
22.1 Anti-asthmatic medicines:
22.1.1 Systemic bronchodilators
22.1.2 Inhalation bronchodilators
22.1.3 Inhalation corticosteroids
22.1.4 Other inhalation products
22.1.5 Other systemic products
22.2 Cough and cold preparations
22.2.1 Antitussives
22.2.2 Expectorants
22.2.3 Decongestants
22.2.4 Mucolytics
22.2.5 Combination products
22.3 Inhalations and vapour rubs
22.4 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
23. Agents correcting or modifying body fluid composition
23.1 Oral:
23.1.1 Oral rehydration products
23.1.2 Oral electrolyte replacement
23.2 Parenteral
23.2.1 Large volume infusions
23.2.2 Injections
23.3 Dialysis products
23.3.1 Peritoneal dialysis solutions
23.3.2 Haemodialysis solutions
23.4 Ion exchange resins
23.5 Agents modifying urinary pH
23.6 Haemoperfusion products
23.7 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
24. Vitamins, minerals and tonics
24.1 Vitamins (excluding combinatins);
24.1.1 Vitamin A and analogues
24.1.2 Vitamin B group (single compounds, except B12, see 10.1.3)
24.1.3 Vitamin C
24.1.4 Vitamin D and analogues
24.1.5 Vitamin E and analogues
24.1.6 Vitamin K and analogues
24.1.7 Other preparations of single vitamins (except folate, see 10.1.2)
24.2 Vitamin B compound preparations
24.3 Multivitamins (excluding vitamins plus minerals)
24.4 Minerals (except iron, see 10.1.1, and electrolytes, see 23.1.2);
24.4.1 Single minerals
24.4.2 Compound preparations
24.5 Vitamins plus minerals
24.6 Tonics
24.6.1 Tonics with vitamins
24.6.2 Tonics with minerals
24.6.3 Tonics with vitamins and minerals
24.6.4 Others
24.7 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
25. Nutritional agents
25.1 Intravenous nutrition preparations
25.2 Milk substitutes
25.3 Special oral foods
25.4 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
26. Enzymes (excluding GI tract)
27. Enzyme inhibitors
28. Medicines used in complementary medicine
[amended by S.I. 199 of 1998 with effect from 7 August,1998.]
28.1 Homeopathic remedies
28.2 Herbal remedies
28.3 Dutch remedies
28.4 Ayurvedic remedies
28.5 Traditional remedies
28.6 Others
29. Radioactive isotopes, and kits for their preparations
29.1 Diagnostic
29.2 Therapeutic
29.3 Others [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
30. Environmental Disinfectants and Decontaminants
31.Miscellaneous [inserted by S.I. 199 of 1998 with effect from 7 August,1998.]
PART II
VETERINARY CLASSIFICATION
800100 Central nervous system stimulants
800110 Respiratory stimulants
800120 Narcotic analgesic antagonists
800200 Central nervous system depressants
800210 Anaesthetics
800211 Inhalants
800212 Injections
800220 Narcotic analgesics
800230 Non-narcotic analgesics and antipyretics
800240 Soporifics, sedatives and hypnotics
800250 Anticonvulsants, anti-epileptics
800260 Tranquillizers and neuroleptics
800261 Phenothiazine derivatives
800262 Butyrophenone derivatives [amended by the Director-General.]
800270 Central acting muscle relaxants
800280 Special agents and medicine combinations used for game immobilization.
800290 Agents for euthanasia
800300 Medicines acting on the muscular system
800310 Peripherally acting muscle relaxants
800400 Local anaesthetics
800410 Injections
800411 Topical
800500 Connective tissue medicines
800501 Anti-inflammatory agents (anti-rheumatics and anti-arthritis)
800511 Non-hormonal preparations
800512 Combinations with corticosteroids
800600 Medicines affecting autonomic functions
800610 Adrenomimetics
800620 Adrenolytics
800630 Cholinomimetics
800640 Cholinolytics
800650 Antihistamines
800700 Cardiac medicines
800710 Cardiac stimulants
800720 Cardiac depressants
800730 Cardiac glycosides
800800 Medicines acting on the blood and the haemopoietic system
800810 Haemostatics and coagulants
800820 Anticoagulants
800830 Haematinics
800900 Medicines acting on the respiratory system
800910 Nasopharyngeal and laryngeal preparations
800920 Expectorants, bronchodilators
800930 Antitussives
801000 Medicines acting on the gastro-intestinal tract
801020 Anti-emetic
801030 Antispasmodics and spasmolytic preparations
801040 Anorexigenics
801050 Antacid preparations
801060 Lubricants. laxatives, purgatives and faecal softeners
801070 Antidiarrhoeals
801071 Plain
801072 Combinations with antimicrobial agents
801080 Digestants
801090 Rumatorics and other preparations used in the ruminant
801100 Medicines acting on the liver
801110 Cholagogues and choleretics
801120 Liver protectants and lipotropic agents
801200 Anthelmintics
801210 Anthelmintics used in livestock
801211 Tramatocides
801212 Cestoicides
801213 Nematocides
801220 Anthelmintics used in small animals
801221 Cestocides
801222 Nematocides
801300 Dermatological preparations
801310 Antiseptic and antibiotic preparations
801320 Cleaning agents
801330 Surface anaesthetics
801340 Antipruritics
801341 Corticosteroids with or without antimicrobial agents
801342 Others
801350 Emollients and protectants
801360 Keratolytics
801370 Topical fungicides
801400 Wound and burn preparations
801410 Wound disinfectants
801420 Wound dressings
801430 Desloughing agents.
801500 Disinfectants
801510 Environmental disinfectants
801520 Instrument disinfectants
801600 Pesticides and control of external parasites
801601 Dusts
801612 Dips
801613 Others
801620 Pesticides used on small animals
801621 Dusts
801622 Dips
801623 Others
801700 Ophthalmic preparations
801710 With antibiotics and/or sulphonamides
801720 With corticosteroids
801730 Combinations of antibiotics and/or sulphonamides with corticosteroids
801740 Others
801800 Aural preparations
801810 With antibiotics and/or sulphonamides
801811 Combinations of antibiotics and/or sulphonamides
801900 Medicines acting on the urinary system
801910 Diuretics
801920 Urolitholytics and urinary tract antispasmodics
801930 Urinary tract antiseptics
801940 Others
802000 Medicines acting on the genital system
802010 Vaginal preparations
802020 Uterine preparations
802030 Uterine antispasmodics
802040 Oxytoxics
802050 Ovulation controlling agents
802060 Prostaglandins
802100 Intramammary preparations
802200 Antimicrobal (chemotherapeutic agents)
802210 Antibiotics and antibiotic combinations
802211 Broad and medium spectrum
802212 Narrow spectrum
802213 Penicillins
802214 Penicillin – streptomycin combinations
802215 Antifungal antibiotics
802216 Topical antibiotics
802220 Sulphonamides and sulphonamide combinations
802230 Nitrofurans and other antibacterial agents
802240 Fungicides
802250 Protozoacides
802251 Coccidiostats
802252 Babesiocides
802253 Others
802300 Biologicals
802310 Vaccines
802311 Horse diseases
802312 Cattle diseases
802313 Sheep diseases
802314 Pig diseases
802315 Dog diseases
802316 Cat diseases
802317 Other species
802400 Hormones, antihormones and oral hypoglyoemics
802410 Insulin preparations
802420 Oral Hypoglycaemics
802430 Thyroid preparations
802440 Corticosteroids
802441 Corticosteroids and analogues
802442 Combinations with antimicrobial agents
802443 Others
802450 Anabolic steroids
802460 Male sex hormones
802470 Female sex hormones
802471 Oestrogens
802472 Progestogens
802480 Androgen-oestrogen combinations
802490 Trophic hormones
802500 Vitamin preparations
802510 Fat-soluble vitamin preparations
802520 B-Complex vitamin preparations
802530 Vitamin C preparations
802540 Composite vitamin preparations
802600 Amino acids and protein hydrolysates
802700 Mineral and nutritional supplements
802800 Tonics and geriatric preparations
802900 Electrolytes and fluids for perenteral administration
802901 Electrolytes and fluids for oral use
803000 Cytostatic and immunosuppressant agents
803100 Chelating agents, heavy metal antidotes and miscellaneous
803200 Contrast media
803300 Diagnostic agents
803400 Enzyme preparations
803500 Growth stimulants 

Countries/Regions affected by the measure.

Description

All countries