|Procedure Name||Registration of drug prior to its sale and distribution|
Drugs Registration Rules, 2038 (1981)
Section 4A. Registration of drug prior to its sale and distribution: (1) For purpose of Subsection (1) of Section 8A. of the Act, an industry having obtained the production license shall, prior to the sale and distribution of each drug manufactured by it, make an application to the Department setting out the following details, in the format as referred to in Schedule-4A., for the registration of the sale and distribution of such drug:
(a) Product specification of the manufactured drug,
(b) Method of analysis of the manufactured drug and test report conducted by a laboratory specified by the Department,
(c) A sample of the manufactured drug, along with the label indicating its price,
(d) Other matters specified by the Department.
(3) Each drug manufacturer who has obtained the product license pursuant to Section 8 of the Act prior to the commencement of these Rules shall register each drug manufactured by it pursuant to these Rule within one year after the date of commencement of these Rules and obtain the drug sale and distribution registration certificate.
|Title||Description||Create Date||Update Date||Issued By||File|
|Name||Measure Type||Agency||Description||Comments||Legal Document||Validity To||Measure Class|
|Registration of drug prior to its sale and distribution||Registration Requirement||Ministry of Health||Section 4A. Registration of drug prior to its sale and distribution||Comments||Drugs Registration Rules, 2038 (1981)||9999-12-31||Goods|