Appendix 7 : Special Conditions For Registration For A Particular Product Or Group Of Products 

User Rating: 0 / 5

Star InactiveStar InactiveStar InactiveStar InactiveStar Inactive
 

 

1. BLOOD PRODUCTS 

  • Each batch of the products must comply with WHO requirements for the product.
  •  Each batch of the product imported into Malaysia must be accompanied with a Batch Release Certificate from the relevant authority in the country of manufacture.
  •  Each batch of the product must be accompanied with a certificate confirming that the blood or plasma used in the production of the lot is tested and found to be negative for HIV antibody, HbsAg, HCV and high-risk donors are excluded.
  •  Each batch of the product must be accompanied with a certificate of analysis. 

 

2. ETRETINATE/ ACITRETIN 

  • The product shall only be sold or supplied to: 
    • Dermatologist (Skin Specialist) who are gazetted with the Ministry of Health, Malaysia, or registered with the Academy of Medicine, Malaysia, Specialist Registry and Approved by the Drug Control Authority.  
    • A hospital or Institution maintained by the government, having the services of a skin specialist or registered medical practitioner with experience in dermatology. 
  • The container of the product shall be labeled in a conspicuous and distinct manner, with the following statements:
    •  “Etretinate/ Acitretin is highly teratogenic.
    •  Pregnancy must be avoided during treatment and for at least three years after completing treatment.” 
  • A proper record of product supplied stating the product name, product registration number, name, address and contact number of purchaser (prescriber) shall be kept and submitted to the Authority upon request. 
  • The following records shall be maintained for the product and well kept for auditing by the Authority. 

 

   

 

3. HUMAN GROWTH HORMONE (Somatotropin, Somatropin) 

  • A proper record of product supplied stating the product name, product registration number, name, address and contact number of purchaser (prescriber) shall be kept and submitted to the Authority upon request.  

 

4. ISOTRETENOIN/ TRETINOIN

  •  The product shall only be sold or supplied to: 
    • Dermatologist (Skin Specialist) who are gazetted with the Ministry of Health, Malaysia, or registered with the Academy of Medicine, Malaysia, Specialist Registry and Approved by the Drug Control Authority. 
    • A hospital or institution maintained by the government, having the services of a skin specialist or registered medical practitioner with experience in dermatology. 
  • The container of the product shall be labelled in a conspicuous and distinct manner, with the following statements: 
    • “Isotretinoin/ tretinoin is highly teratogenic. 
    • Pregnancy must be avoided during treatment and for at least 1 month after completing treatment.” 
  • A proper record of product supplied stating the product name, product registration number, name, address and contact number of purchaser (prescriber) shall be kept and submitted to the Authority upon request.

 

 5. KETOCONAZOLE 

  • Products containing oral ketoconazole are restricted for hospital use only. 

 

6. MIDAZOLAM 

  • Products containing midazolam are restricted for use in government and private hospitals and specialist clinics only. 

 

 7. PARACETAMOL IN COMBINATION WITH CAFFEINE

  • For products containing a combination of paracetamol and caffeine, dose unit of caffeine for adults is 65mg and maximum dose of caffeine is 520mg per day, meanwhile, dose unit for paracetamol is 500mg with the maximum dose of 4,000mg per day or 8 tablets daily.
  •  Products containing caffeine for pediatrics are not allowed.
  •  Allowable packing size should not exceed 20 tablets/ capsules.

 

 8. PARACETAMOL INTRAVENOUS INJECTION

  •  Products containing paracetamol in the form of intravenous injection are restricted for hospital use only.

 

9. VACCINES

  •  Each batch of the product must comply with WHO requirements for the product.
  • Each batch of the product imported into Malaysia must be accompanied with a batch release certificate.

 

 

 

 

 

 

 

 

 

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

DISCLAIMER

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.

Mobile Web :

© Copyright 2018 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA