(1999; 168 pages) [Spanish]
Part F. Interpretation
22. The legislation should include an interpretation of terms which may be used in a special context. In the model text given here, terms which might need interpretation include:
"Appointed date" means the date specified under section 5.1 of the Law.
"Inventory" refers to the listing of provisionally registered/authorized medicinal products under section 5.2 of the Law.
"Medicinal product" means any medicine intended for human or veterinary use, presented in its finished dosage form or as a starting material for use in such dosage form, as defined in paragraph 5, p. 106 (see also p. 111).
"Minister" means the minister responsible for matters relating to medicinal products.
"Person" includes an individual as well as a body corporate, partnership or association of persons, and establishments such as hospital pharmacies, clinics, and health centres storing or distributing medicinal products.
"Provisionally authorized/registered" is used in relation to a medicinal product which has been listed in the inventory under section 5 of the Law and which has not been screened for purposes of a product licence/marketing authorization under sections 6 and 9 of the Law.
"Register" means the register of medicinal products for which a product licence/marketing authorization has been issued in terms of sections 6 and 9 of the Law or the register of persons, i.e. the pharmacist and pharmacy assistant.
"Sell" means to sell for cash or on credit or by way of exchange, whether by wholesale or retail; "sale" shall have a corresponding meaning.
The above are some of the more important terms used in the legislative scheme which need to be defined, but other terms may also require definition. The WHO text on Good manufacturing practices for pharmaceutical products (see Appendix 2) contains a number of definitions of terms such as "manufacture" which can be included, after adaptation if necessary, in the definition section.