(1999; 168 pages) [Spanish]
Part D. Other activities requiring authorization/licensing
13.1 On or after such date as is specified in a notice published in the gazette or in any official publication as may be specified in the regulation, a person carrying on a business of manufacturing, importing, exporting, compounding, storing, dispensing, selling, supplying or otherwise distributing medicinal products must possess a valid authorization/licence in order to carry out that activity.
13.2 The licensing authority shall maintain a register of pharmacies. An application for registration of pharmacy premises under this section must be made in accordance with regulations issued by the minister.
13.3 The particulars to be furnished by applicants for an authorization/licence, their qualifications and suitability, and the terms, requirements and conditions under which such authorizations/licences may be granted, shall be specified by the drug regulatory authority in regulations made under the Law.
13.4 Any person aggrieved by a decision of the drug regulatory authority may appeal, within two weeks of the notification of the decision of the drug regulatory authority, to the minister/authority.
13.5 On receipt of an appeal the minister/authority may decide whether or not the drug regulatory authority should be directed to rescind, suspend, vary, modify, reconfirm or reconsider the order in respect of which the appeal has been lodged.
Parts B and C were concerned with medicinal products, whereas Part D deals with individuals, companies, firms, hospital clinics or dispensaries, pharmacies, etc., who need a licence/authorization to engage in various activities.
There is a right of appeal to the minister/authority against any decision of the drug regulatory authority. Provision for administrative relief in the first instance is important, as litigation generally tends to be protracted, costly and inconvenient for all parties concerned.