General Conditions For Registration Of Drug Products Under The Control Of Drugs And Cosmetics Regulations 1984

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6.1 : Registration Code/ Number
6.2 : Product Particular
6.3 : Labelling And Packaging
6.4 : Product Authentication
6.5 : Indications, Special Conditions
6.6 : Adverse Reactions, Complaints
6.7 : Holder Of Registered Product
6.8 : Withdrawal From Registration
6.9 : Cancellation, Suspension, Amendment By The Authority
6.10 : Directives
6.11 : Conditions Pertaining To Patent

 

 

6.1   REGISTRATION CODE/ NUMBER

 

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. MAL11070001ACERSY:

  • MAL refers to “Malaysia”
  • YYMM refers respectively to year and month of registration by the Authority (e.g. 1107: July 2011);
  • $$$$ refers to a serial number for a product being registered (e.g. 0001);
  • @ refers to category of product being registered i.e. A/ X/ N/ T/ H; and
  • ## refers to administrative code used by NPRA i.e. C/ E/ R/ S/ Y.
  • The symbols @ and ## refer to:
  • A= Scheduled Poison
  • X= Non-scheduled Poisons
  • N= Health Supplements
  • T= Natural Products/ Traditional 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)
  • Y= Orphan products
  • Z= Products gazetted as zero-rated under the Goods and Services Tax Act
    2014, Goods and Services Tax (Zero-Rated Supplies) Order 2014.

 

 

 

 

6.2   PRODUCT PARTICULAR

The holder of the registered product shall supply such documents, items, samples, particulars or information as the Authority may require in relation to the registered product.
No change in name, composition, characteristics, origin, specifications, manufacturer, packing, indications, labeling, package insert, product literature or any relevant particulars of the registered product shall be made without prior approval of the Authority.

 

 

 

 

6.3   LABELLING AND PACKAGING

6.3.1 SHRINK WRAPPING

Shrink wrapping of multiple boxes of approved pack sizes are allowable provided the following conditions are met:

        • This refers to multiple boxes of approved pack sizes of a single or multiple registered products which are shrink wrapped and marketed together for convenience of the consumers.
        • This only applies to registered products from the Health Supplements, Natural Products/ Traditional Medicines and Non-scheduled Poisons category (category T, N and X).
        • The shrink wrap does not come into contact with the dosage form.
        • There are no qualitative or quantitative changes to the approved registered primary packaging and the outer packaging.
        • There are no changes to the label contents of the product, and the label contents are not obscured.
        • The shrink wrap used must be completely transparent and does not contain any stickers/ wordings/ graphics.

 

 

 

 

 

6.4   PRODUCT AUTHENTICATION

 

The registered product shall be affixed with the security device approved by the Authority. The said security device (hologram), which is serialized, shall be used to authenticate and verify that the product is registered with the Authority, and will be affixed to each unit pack of the product, whether locally manufactured or imported.

The security device shall be affixed onto the outer packaging of the product, (or, where there is no outer packaging, on the immediate packaging), on the front panel of the product label. None of the product particulars on the label shall be covered over by the security device.

Please refer to:

  • Appendix 9: Labelling Requirements where the security device/ label may be affixed on the product label;
  • FAQ no. 20 on hologram; and
  • Circulars and directives pertaining to security label (hologram):
  • Bil (32) dlm BPFK/02/5/1.3

Keputusan Mengenai Tarikh Perlaksanaan Penggunaan Label Hologram Meditag (6 August 2004)

Keputusan Pihak Berkuasa Kawalan Dadah Berhubung Penggunaan Label Hologram (Product Authentication) (5 November 2004)

Menaiktaraf Ciri-ciri Keselamatan Label Meditag (15 August 2006)

Peraturan-peraturan Kawalan Dadah dan Kosmetik 1984. Arahan Pengarah Kanan Perkhidmatan Farmasi Bil 2 Tahun 2013 : Direktif Pelaksanaan dan Pengendalian Label Keselamatan (4 April 2013)

Direktif Berhubung Penggunaan Label Keselamatan Hologram Meditag™ 4

 

 

 

 


6.5   INDICATIONS, SPECIAL CONDITIONS

 

The registered product shall only be indicated for use as approved by the Authority. The importation, manufacture, sale and supply of the registered product shall comply with all other specific conditions imposed by the Authority.

 

 

 

 

6.6   ADVERSE REACTIONS, COMPLAINTS

 

The product registration holder or any person who possesses any registered product shall inform the Senior Director of Pharmaceutical Services immediately of any adverse reactions arising from the use of the registered product.

 

 

 

 

6.7   HOLDER OF REGISTERED PRODUCT

 

The holder of the registered product shall inform the Authority of any change in his name or address.

 

 

 

6.8   WITHDRAWAL FROM REGISTRATION

 

The holder of the registered product shall notify the Authority with regards to any decision to withdraw registration of a product and shall state reasons for the decision.

The holder shall also notify the Authority when he is no longer authorized to be the holder of the registered product

 

 

 

 

6.9   CANCELLATION, SUSPENSION, AMENDMENT BY THE AUTHORITY

 

The Authority may, at any time and without assigning any reason suspend or cancel the registration of any product, and may amend the conditions of registration.

 

 

 

6.10 DIRECTIVES

 

The Senior Director of Pharmaceutical Services may issue written directives or guidelines to any person or a group of persons as he think necessary for the better carrying out of the provisions of these Regulations and which in particular relate to:

  • Product quality, safety and efficacy;
  • Labeling;
  • Change of particulars of a product;
  • Transfer of licenses;
  • Manufacturing;
  • Storage includes requirements as to containers;
  • Retailing;
  • Promotion of sale including product information;
  • Product recall;
  • Product disposal;
  • The cost of product recall or product disposal;
  • Clinical trials; or
  • Records and statistics pertaining to manufacture, sale, supply, import or export of any products.

 

 

 

 

6.11 CONDITIONS PERTAINING TO PATENT

For the purpose of registration of generic products, PRH shall provide patent declarations as below:

  • PRH shall comply with all legal provisions in Malaysia;
  • The government/ authority is not liable for any offence committed by the PRH as a result of any breach of any law; and
  • PRH shall indemnify the government if any claim is made against the government as a result of any breach of any law by the applicant whether intentionally or otherwise.

PRH shall conform to Patent Act 1983 (Act 291) and shall not market, sell, offer for sale, or store any registered product containing any patented active ingredient(s) of which the patent duration is yet to expire.

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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