(1999; 168 pages) [Spanish]
Part E. General provisions
14. It shall be an offence under this Law for any person to manufacture, import, sell or export a product after the appointed date unless such product at the time of manufacture, import, distribution or export has the status of a provisionally authorized/registered medicinal product under section 5.2 or has received a product licence/marketing authorization under section 6.
This section deals with the situation in which a product which is neither provisionally authorized/registered nor covered by a product licence/marketing authorization is manufactured, imported, distributed, sold or exported after the appointed date.
15. After such date as is specified under section 13.1 of the Law, it shall be an offence for any person to engage in any of the activities mentioned in that section, unless this person holds a valid authorization/licence granted by the drug regulatory authority or is otherwise legally entitled to engage in any such activity.
This section deals with the situation in which a person engages in an activity mentioned in section 13 without a licence or legal right (under another law).
16.1 No person shall manufacture, import, export, compound, store, sell, promote or distribute a medicinal product:
(a) that is unfit for use in humans or in animals;
(b) that is adulterated;
(c) that contains any natural or added deleterious substance which renders it injurious to health;
(d) that has been manufactured, prepared, preserved, packaged or stored for sale under insanitary and/or unfavourable conditions; or
(e) that has been labelled, packaged or promoted in a manner that is false, misleading, deceptive or likely to create an erroneous impression regarding its source, character, value, quality, composition, potency, merit or safety.
16.2 No person shall manufacture, import, export, distribute, sell, supply or use any counterfeit starting materials.
16.3 No person shall manufacture a medicinal product using any counterfeit starting materials or without taking reasonable measures to ensure that the starting materials used in the manufacture of such medicinal products are not counterfeit or of suspect quality.
16.4 No manufacturer, importer, exporter, distributor, pharmacist, health practitioner, health worker or other person shall manufacture, import, export, compound, prepare, promote, sell, supply, obtain, display, dispense or otherwise distribute, for a fee or by way of sample or gift, any medicinal product which is a counterfeit or known or suspected to be a counterfeit.
This section is of a general nature aimed at ensuring that only medicinal products which meet acceptable standards are marketed.
One potential problem area in implementing this provision is the lack of quality control facilities where products could be tested and verified in small developing countries. Through cooperative arrangements with neighbouring countries with good quality control facilities, however, it should be possible to have products tested there. Participation in the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce also provides an opportunity for quality defects to be investigated.
17. Where any standard is prescribed for any medicinal product, no person shall label, package, sell, offer for sale, distribute or promote any such medicinal product which does not conform to such standard in such a manner that makes it likely to be mistaken for the medicinal product for which the standard has been prescribed.
The applicable standards will have to be specified in the regulations.
18.1 The drug regulatory authority or any authorized officer shall have the power to visit and inspect any manufacturing plant, processing unit, business establishment, warehouse, office, or any premises used for or in connection with the manufacture, import, export, distribution, storage, sale, supply, dispensing or use of any medicinal product, to take samples of any medicinal product or of any substance, and to examine records or other documents relating to any medicinal product.
18.2 No person shall refuse to permit the drug regulatory authority or any authorized officer to enter and inspect or take samples or documents.
18.3 An inspector may at any reasonable time and on production of his or her certificate of authority enter any premises:
(a) for the purpose of ascertaining whether there is or has been any contravention of the legislation;
(b) generally, for the purpose of discharging his or her functions under the legislation.
18.4 An inspector may:
(a) inspect the premises, any article and any document for the purposes of the legislation;
(b) seize any substance, article or document which he or she has reasonable cause to believe to be a substance, article or document in which or by means of which an offence under the legislation is being or has been committed.
"Premises" for the purposes of this section includes any premises, ship, aircraft or vehicle. "Premises" does not include a private residence.
It will be useful to develop a plan of action, with appropriate checklists and guide, to enable authorized officers to conduct inspections.
19. Any person who contravenes or fails to comply with any provision of this Law or any regulation or any order made under this Law shall be guilty of an offence, and on conviction shall be liable to a fine between .......... and .............. or imprisonment for a term not exceeding ............. months/years, or both; in the case of a continuing offence, to a fine not exceeding ................... for every day or part of a day during which the offence has continued.
The minimum and maximum penalties (imprisonment and/or fine) must be determined in line with the penalties generally prescribed by other laws currently in force in the country.
The need for "deterrent penalties" must be carefully balanced against the risk of "overkill". Too high a penalty, particularly one entailing mandatory jail sentences, for instance, can lead to lax enforcement and will be counterproductive in the long run. On the other hand, products like medicinal products need to be manufactured and handled with great care; any deliberate or negligent departure from established standards and norms can result in otherwise avoidable mortality and morbidity. The ubiquitous problem of counterfeit drugs has reinforced the need for severe penalties for certain types of violations involving deliberate or fraudulent behaviour.
20. The provisions of this Law shall extend to all persons, in both the public and private sectors, engaged in manufacturing, importing, exporting, compounding, storing, distributing, promoting, selling or in any other way dealing with medicinal products.
In some countries express statutory provision is required in order for a law to apply to the state or to the public (government) sector. It is important that regulatory controls apply to all medicinal products, irrespective of who is responsible for their manufacture, import or export, distribution or sale.
21. Regulations shall be made for all or any of the matters for which the Law provides for regulations to be made and, in particular, for the following purposes:
(a) Prohibiting, limiting, restricting, or imposing conditions on, either generally or in relation to: (i) a particular medicinal product; (ii) the manufacture, import, export, compounding, dispensing, administration, sale or supply of medicinal products; (iii) printed packaging material, package leaflets and data sheets/product information, promotion to health professionals, advertising to the general public and conduct of marketing practices.
(b) Withdrawing medicinal products from sale or distribution.
(c) Prescribing the standards to be followed in the manufacture, storage, sale, supply, dispensing and distribution of medicinal products.
(d) Classifying medicinal products for purposes of regulating importation, manufacture, compounding, prescribing, dispensing, selling, storage and distribution.
(e) Regulating persons entitled to import, manufacture, compound, export, store, prescribe, dispense or sell medicinal products.
(f) Prescribing the terms, conditions, procedures and time-limit for the issuance of licences/authorizations under Parts C and D of the Law and the forms, fees, particulars and records necessary for applications for licensing and grounds for suspension, cancellation or withdrawal of licences/product authorizations.
(g) Regulating the composition and terms of reference of the medicinal products advisory committee and/or board of medicinal products,
(h) Granting exemptions from the requirement of a product licence/marketing authorization for imports of medicinal products required for a named patient or to meet a public health emergency.
(i) Designating laboratories and analysts for the purposes of conducting analyses and submitting reports.
(j) Regulating the licensing/authorizing and licensing/authorization renewal fees in order to support the drug regulatory functions.
(k) Prescribing any regulation in matters pertaining to this Law.
(l) Regulating clinical trials on medicinal products.
(m) Regulating drug donations.
(n) Regulating the obligation to report on drug adverse reactions.
(o) Regulating the obligation to report on product variations such as quality or manufacturing change.
There are a number of sections which provide for regulations to be made. This catalogue is in addition to the matters referred to in those sections.