Step 3 of 4: Regulatory Outcome

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5.0   REGULATORY OUTCOME

5.1 DECISIONS OF THE AUTHORITY

A regulatory decision shall be made based on the outcome of the evaluation of the submitted documentation, and samples (if applicable). An application may be approved or rejected by the Authority, and the Authority decision will be sent via email/ official letter to the product registration holder.

As stipulated under the CDCR 1984, Regulation 11(1), the Authority may, at any time reject, as well as cancel or suspend the registration of any product if there are deficiencies in safety, quality or efficacy of the product or failure to comply with conditions of registration.

 

5.2 PRODUCT REGISTRATION NUMBER

As stipulated in Regulation 8(8), CDCR 1984, upon registration of a product by the Authority, the product registration holder shall be notified by the Authority and a product registration number (i.e. MAL number) shall be assigned to the registered product via the system.

The registration number is specific for the product registered with the name, identity, composition, characteristics, origin (manufacturer) and product registration holder, as specified in the registration documents. It shall NOT be used for any other product.

 

5.3 CERTIFICATE OF REGISTRATION

Correspondence via the system shall be sent to the applicant if there is any clarification and further supplementary data/ information or documentation pertaining to the application, if deemed necessary by the Authority.

Applicant shall refer to the product registration approval notification sent by the Authority or the Approved Product Registration List in NPRA website.

Reference: Circular (100)dlm.BPFK/PPP/01/03 Jld. 2. Pemansuhan Pengeluaran Sijil Perakuan Pendaftaran (SPP) (21 January 2013). 

 

POST-REGISTRATION PROCESS

Registration status of a product shall be valid for five (5) years or such period as specified in the Authority database (unless the registration is suspended or cancelled by the Authority).

 

Upon approval for product registration by the Authority, applicants shall fulfill all commitments and conditions imposed during approval of the product registration and shall be responsible for the maintenance of the product in terms of quality, safety and efficacy throughout the validity period of registration. Failure to do so may result in rejection of application for renewal of product registration.

The Authority shall be notified of any changes to the product’s efficacy, quality and safety, as described in detail at Section E: Post-Registration Process.

 

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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