(1999; 168 pages) [Spanish]
Part B. Provisional registration/marketing authorization and inventory of medicinal products
5.1 The drug regulatory authority shall, by order published in the gazette [variant: or through other means of notification], require manufacturers, importers and exporters of medicinal products to notify the drug regulatory authority of such particulars as are specified in the order concerning the medicinal products which such manufacturers, importers, or exporters wish to continue to manufacture, import, export or sell after such date (hereafter referred to as the appointed date) as is specified in the order.
5.2 Medicinal products for which a notification has been received by the drug regulatory authority on or before the appointed date shall be listed in the provisionally authorized/registered medicinal products inventory (hereafter referred to as the inventory), and until granted a product licence/marketing authorization or ordered by the drug regulatory authority (or board) not to be manufactured, imported, exported or sold, such products shall have the status of provisionally authorized/registered medicinal products.
5.3 After the appointed date no person shall import, manufacture, export or sell a medicinal product not listed in the inventory without the prior written permission of the drug regulatory authority unless a product authorization/licence has been granted in respect of such product under section 6 of this Law.
5.4 The inventory, the format of which may be laid down in regulations, shall be made available for inspection at such place and at such times as specified by the drug regulatory authority in an order published in the gazette or one or more newspapers as may be specified in the regulations.
5.5 The inventory shall be revised accordingly as and when provisionally authorized/registered products listed therein have been granted a product authorization/licence under section 6.1, or the drug regulatory authority has ordered under section 6.3 that any such provisionally authorized/registered medicinal product should not be manufactured, imported, exported or sold from such date as is specified in the order.
This section provides for a system of provisional authorization/registration for medicinal products which are being manufactured, imported, exported or sold from a specific date, and which will be continued to be manufactured, imported, exported or sold even after that date (appointed date).
Medicinal products which are notified on or before the appointed date will be listed in a provisionally authorized/registered medicinal products inventory. The scheme envisages this inventory as well as a register. The latter is for medicinal products which have been granted a product licence/marketing authorization. The procedure for screening provisionally authorized/registered products, as well as new applications for other medicinal products, is contained in section 6.
For a provisionally authorized/registered medicinal product, the drug regulatory authority may decide one of two things: either to grant a product licence/marketing authorization, or to phase out or ban its manufacture, import, sale or export. In either event, the product will be deleted from the inventory. If a product licence/marketing authorization is granted, it will be entered in the register of medicinal products for which a product licence/marketing authorization has been granted (see section 9).
At some point - depending on the pace at which the screening process can proceed - the inventory will cease to exist, as all products which had the provisionally authorized/registered status would have been screened and either granted a product licence/marketing authorization or eliminated from the market.
Section 14 makes it an offence to manufacture, import, sell or export a product unless it has a marketing authorization or is deemed to be provisionally authorized/registered.
A renewal process will be established at regular intervals for those products which show satisfactory performance in the market and comply with regulations.