(1) The Federal Government shall cause all drugs to be registered in-accordance with such conditions and procedure as may be prescribed and for that purpose set up a Registration Board, consisting of such number of persons, possessing such qualifications, as may be prescribed. Explanation: In this section, "drugs" means drugs which are in the finished form ready for use.
(2) The members of the Registration Board shall exercise such powers, including the powers of an Inspector, as may be prescribed.
(3) The Registration Board shall, [with the approval of the Federal Government and by notification in the official gazette,] make regulations to regulate the conduct of its business.
(4) Any member of the Registration Board may, at any time, by writing under his hand addressed to the Federal Government, resign .his office or shall vacate his office if the Federal Government, being of opinion that in the public interest it is necessary so to do, so directs.
(5) Subject to sub-section (4), the members of the Registration Board shall hold office for the prescribed period.
(6) The Federal Government shall, by notification in the official Gazette, fix the date after which no drug which is not registered shall be allowed to be exported, imported, manufactured, stored, distributed or sold.
(7) A person applying for the registration of a drug shall furnish such information in respect of the drug as may be prescribed, including information relating to its efficacy, safety, and quality, or as may be required by the Registration Board for the purpose of the evaluation of the drug.
(8) Single-ingredient drugs shall be registered generally by their generic names while compound drugs shall be registered generally by their proprietary names.
Explanation: In this sub-section,--
(a) "single-ingredient drugs" means drugs containing one active ingredient;
(b) "compound drugs" means drugs containing more than one active ingredient.
[(9) The registration of a drug shall be subject to such conditions as may be prescribed.]
(10) Where the Registration Board registers a drug, it shall inform the person applying for its registration and the Provincial Governments of its having done so and of the conditions subject to which it has been registered.
(11) If the Registration Board, on the basis of information received or an inquiry conducted by it, is of opinion that--
(a) the registration of a drug was procured by fraud or misrepresentation; or
(b) the circumstances in which a drug was registered no longer exist; or
(c) there has been a violation of the conditions subject to which a drug was registered; or
(d) it is necessary in the public interest so to do;
the Registration Board may, after affording to the person on whose application the drug was registered an opportunity of showing cause against the action proposed to be taken, cancel or suspend the registration or specify any further conditions to which the registration shall be subject and inform such person and the Provincial Governments accordingly.
(12) The Provincial Governments shall take all such steps as may be necessary to ensure compliance with the conditions subject to which a drug is registered and to prevent the manufacture or sale of a drug--.
(a) which has not been registered; or
(b) the registration of which has been cancelled or stands suspended.
(2) The members of the Registration Board shall exercise such powers, including the powers of an Inspector, as may be prescribed.
(3) The Registration Board shall, [with the approval of the Federal Government and by notification in the official gazette,] make regulations to regulate the conduct of its business.
(4) Any member of the Registration Board may, at any time, by writing under his hand addressed to the Federal Government, resign .his office or shall vacate his office if the Federal Government, being of opinion that in the public interest it is necessary so to do, so directs.
(5) Subject to sub-section (4), the members of the Registration Board shall hold office for the prescribed period.
(6) The Federal Government shall, by notification in the official Gazette, fix the date after which no drug which is not registered shall be allowed to be exported, imported, manufactured, stored, distributed or sold.
(7) A person applying for the registration of a drug shall furnish such information in respect of the drug as may be prescribed, including information relating to its efficacy, safety, and quality, or as may be required by the Registration Board for the purpose of the evaluation of the drug.
(8) Single-ingredient drugs shall be registered generally by their generic names while compound drugs shall be registered generally by their proprietary names.
Explanation: In this sub-section,--
(a) "single-ingredient drugs" means drugs containing one active ingredient;
(b) "compound drugs" means drugs containing more than one active ingredient.
[(9) The registration of a drug shall be subject to such conditions as may be prescribed.]
(10) Where the Registration Board registers a drug, it shall inform the person applying for its registration and the Provincial Governments of its having done so and of the conditions subject to which it has been registered.
(11) If the Registration Board, on the basis of information received or an inquiry conducted by it, is of opinion that--
(a) the registration of a drug was procured by fraud or misrepresentation; or
(b) the circumstances in which a drug was registered no longer exist; or
(c) there has been a violation of the conditions subject to which a drug was registered; or
(d) it is necessary in the public interest so to do;
the Registration Board may, after affording to the person on whose application the drug was registered an opportunity of showing cause against the action proposed to be taken, cancel or suspend the registration or specify any further conditions to which the registration shall be subject and inform such person and the Provincial Governments accordingly.
(12) The Provincial Governments shall take all such steps as may be necessary to ensure compliance with the conditions subject to which a drug is registered and to prevent the manufacture or sale of a drug--.
(a) which has not been registered; or
(b) the registration of which has been cancelled or stands suspended.
No comments:
Post a Comment