Section 11
Registration of medicinal products
(1)
The Authority may, on application made in such manner and form as it may require, register any medicinal product subject to such conditions as it may impose.
(2)
Every application for the registration of a medicinal product shall be accompanied by —
(a)
the prescribed processing fee for that type of product; and
(b)
such documents, items, samples, particulars and other information as the Authority may require.
(3)
The Authority may charge an applicant such costs as it may incur for the purposes of carrying out any laboratory investigation prior to the registration of the medicinal product.
(4)
The processing fee and such costs as may be charged by the
Authority under subsection (3) shall not be refundable.
(5)
Any change in any document, item, sample, particulars or other information mentioned in subsection (2)(b) shall be notified in writing by the applicant to the Authority within 14 days from the date of such change.
(6)
Subject to section 20, the period of registration of a medicinal product shall be as specified in the product licence issued under subsection (8) and where so specified the registration shall be valid till the end of the specified period.
(7)
Subject to section 20, where the period of registration of a medicinal product is not specified the registration shall be valid until it is cancelled.
Medicines
B.L.R.O. 5/2024 21
(8)
Upon registration of a medicinal product, the Authority shall issue to the applicant a product licence.
(9)
Any person who knowingly supplies any false or misleading information to the Authority in connection with an application for the registration of a medicinal product is guilty of an offence.