Step 3 of 4: Regulatory Outcome

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11.0   REGULATORY OUTCOME

11.1 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’s decision will be sent via email/ official letter to the PRH.

As stipulated under Regulation 11(1), CDCR 1984, , 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.

Re-submission of product registration for a rejected application due to safety and efficacy reasons shall not be accepted within two (2) years after the rejection. However, if the product is registered in the reference countries, submission of application may be made earlier. 

11.2 PRODUCT REGISTRATION NUMBER

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

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

The product registered with the registration number as stated in the Authority database shall have the name, composition, characteristics, specifications and origin as specified in the registration documents and Authority database.

Registration number appears as MALYYMM$$$$@##,

e.g. MAL11070001ACERS: 

Alphabets/ symbols Refers to:
MAL "Malaysia"
YYMM Refers to the year and month of registration by the Authority (e.g. 1107: July 2011)
$$$$ Serial number for a registered product (e.g. 0001) 
@ Category of registered product i.e. A/ X/ N/ T/ H
## Refers to administrative code used by NPRA i.e. C/ E/ R/ S
@ and ## A : Scheduled Poison
  B : Natural Products with Therapeutic Claim
  X : Non-scheduled Poisons
  N : Health Supplements
  T : Natural Products (Traditional and Homeopathic Medicines)
  H : Veterinary Products
  C : Contract Manufactured (the product is manufactured by a GMP certified contract manufacturer)
  E : For Export Only (FEO) (the product is to be sold for export only and not for sale in the local market)
  R : Packed and/or repacked (the product is packed and/or repacked by an approved GMP certified packer and/or repacker)
  S : Second source (the product is from a second source/ approved second manufacturer)
  Z : Products gazetted as zero-rated under the Goods and Services Tax Act 2014, Goods and Services Tax (ZeroRated Supplies) Order 2014

 

 

 

11.3 CERTIFICATE OF REGISTRATION

Form 1 (Certificate of Registration) for a product with the provisions, conditions, limitations and etc. of the registration, as stipulated under Regulation 8(8) of CDCR 1984, has been deleted from the regulation in 2006 via amendment of PU(A) 336/06. Therefore, the certificate will no longer be issued by the Authority.

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

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

 The 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, the applicant shall fulfill all commitments and conditions imposed with 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 future application for renewal of the product registration.

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

11.4  APPEAL TOWARDS DECISION OF THE AUTHORITY

Refer to Appendix 24: Appeal

 

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 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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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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