4.3 : Amendment to the particulars of the product

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 4.3.0

Amendment to the particulars of the product

4.3.1 
4.3.2 
4.3.3 
4.3.4 
4.3.5 
   

  

 

 

 

4.3.0 :AMENDMENTS TO PARTICULARS OF A REGISTERED PRODUCT

 

Throughout the life cycle of a registered product, changes to improve the product’s efficacy, quality and safety are likely to occur. Therefore, applicant shall inform the Authority pertaining to any changes or amendment made to particulars of a registered product via variation applications.

 

An applicant who wishes to apply for any application for imported products of which GMP requirement is a consideration, such as change of manufacturing site and variation, shall comply with the requirement, as stated in directive issued by the Director of Pharmaceutical Services under Regulation 29, CDCR 1984. The Authority shall not consider any application in which the requirement is failed to comply with.

Reference:

a)    Bil (25) dlm BPFK/PPP/01/03 Jld 1 

Arahan Pengarah Kanan Perkhidmatan Farmasi Bil 1 Tahun 2012 : Syarat Pendaftaran Produk Farmaseutikal Dari Luar Negara Berkaitan Keperluan Amalan Perkilangan Baik (APB) (09 February 2012)

b)    Bil (96)dlm.BPFK/PPP/01/03 Jld. 2

Surat Pekeliling Bagi Direktif Mengenai Syarat Pendaftaran Produk Farmaseutikal Dari Luar Negara Berkaitan Keperluan Amalan Perkilangan Baik (APB) (28 December 2012)

 

 

 

 

4.3.1 : VARIATION

 

Variation refers to change of particulars of a registered product.

 

a)   For pharmaceutical products, there are three (3) types of variation, which are Major Variation (MaV), Minor Variation Prior Approval (MiV-PA) and Minor Variation Notification (MiV-N). For details, please refer Malaysian Variation Guideline (MVG).

b)   For health supplement and natural product, there are three (3) types of variation, which are Major Variation (MaV), Minor Variation Prior Approval (MiV-PA) and Minor Variation Notification (MiV-N).  For details, please refer Malaysian Variation Guideline (MVG) For Natural (Traditional Medicine & Homeopathy) And Health Supplement Products (Abridged Evaluation).

 

c)    For biologic products, please refer to the Malaysia Variation Guidelines for Biologics (MVGB) and Section E: 16.1.3 Variation Application for Biologic Products.

 

No change of any particulars of a registered product (except for Minor Variation Notification) shall be made without prior approval from NPRA. The registration of a product shall be reviewed for suspension or cancellation if changes are made without prior approval of the Authority.

 

 

For More Detail on Variation : 

Variation Application For Pharmaceutical Products 

Variation Application For Health Supplement And Natural Products  

Variation Application For Biological Products

 

 

 

4.3.2 : Change Of Manufacturing Site (COS) Application

 

Change of Manufacturing Site (COS) refers to change of manufacturing site for certain part or all of the manufacturing process of a product, but it does not cover changes related to a new site, where only:

a)    batch release takes place OR

b)    to a new packager (secondary packaging or labelling), as these changes are covered under applications for amendments to the particulars of a registered product (variation). Please refer to paragraph Variation.

However, a change of manufacturing site for biologics shall require a new product registration if the change is extensive and will have an impact on the quality, safety and efficacy profile of the final product.

Upon receipt of complete application, the application shall be processed within sixty (60) working days.

 

 

 

 

 

 

4.3.3 Change Of Product Registration Holder

 

              A transfer procedure for the purpose of changing the existing product registration holder (PRH) that is authorized to market a registered product in Malaysia to another holder.  This procedure allows the registered product to maintain the same                registration number. 

              Upon receipt of complete online application via QUEST system and hardcopy of original documents, the change of PRH application shall be processed within forty-five (45) working days.

 

 

   
   
   
   
   
   
   
   

  

 

 

 

 

4.4.4    NEW/ ADDITIONAL INDICATION

 

New/ additional indication is defined as an indication which is not initially approved for a registered pharmaceutical product. This shall include new therapeutic indication or indication for new age group, such as usage in children, and shall not include changing/ rephrasing of sentences.

 

There are two (2) types of evaluation process available for a new/ additional indication application: 

 

4.4.4.1        FULL EVALUATION PROCESS

 

For new indication which has been registered in any one of the Authority’s eight (8) reference countries (United Kingdom, Sweden, France, United States of America, Australia, Canada, Japan and Switzerland). 

This application will require specialists’ comments.

 

 

4.4.4.2        VERIFICATION PROCESS

 

For new indication which has been registered by any two reference country’s authorities (United Kingdom, Sweden, France, United States of America, Australia, Canada, Japan, Switzerland and EMA).

 

Note:

The approved new indication in these countries should be the same as that of the proposed new indication.

 

Other supporting documents that are deemed necessary shall be submitted upon request to support the efficacy and safety of the proposed additional indication. 

The supporting documents may include but not limited to the following:

 

a)        Approval of Additional Indication(s) in country of origin;

b)        Approval status in reference countries, its corresponding approval letter and approved Package Insert;

c)        Approval Indication status in ASEAN Member States and its approved corresponding package insert;

d)        Revised Package Insert;

e)        World Wide Approval status;

f)         Consumer Medication Information Leaflet (RiMUP);

g)        Clinical Expert Reports;

h)       Synopsis of Individual Studies;

i)         Clinical Studies Report/ In-House Clinical Trials;

j)          Published Clinical Papers;

k)        Current Periodic Safety Update Report (PSUR).




 

4.4.5    APPLICATION FOR A CONVENIENT PACK

 

a)        This type of application is referring to registered products which are packed together in a single packaging unit for convenience of the consumers, such as a Confinement Set or Set Jamu Bersalin. 

b)        Individual registered products are allowed to be packed together and marketed as a convenient pack, provided that the application is justified satisfactorily. 

c)        The convenient pack is applicable for registered products in the categories of;

i)     Health supplements.

ii)    Natural products.

Or registered products from both categories (i) and (ii)

iii)   Non-Scheduled Poison (OTC)

(Only between OTC products with Abridge Evaluation category) 

d)        Application for a convenient pack shall be made via the process of variation Type II. 

The holder has to submit the convenient pack label and also the individual label via application for variation under Part D2 (outer label). The convenient pack label shall contain the same information as in the primary label. 

For details of variation, please refer to Section E: 16.1 Variation. 

e)        Individual registered products involved in the convenient pack can be sold individually or as a pack. 

f)         Conditions for application:

i)     Individual registered products proposed to be packed together as a convenient pack shall be sourced from the same product owner/ PRH; 

ii)    Submission of the application shall be made by the same PRH. 

iii)   The manufacturing site for the convenient pack shall be a GMP certified facility. 

g)        Approved indication of each individual registered product in the convenient pack remains unchanged. There is no common specific indication for the convenient pack.

h)       Labelling requirement specifically for convenient pack:

 

                        Table XIX:

 

Outer Label

Immediate Label

Contents in the labelling of each individual registered product have to be included in the outer label of the convenient pack.

As per labelling requirements for registered products.

 

Note:

For the purpose of application submission, if the individual registered product is also marketed independently, outer label of the packaging sold independently and outer label of the convenient pack shall be submitted together.

   

i)         Additional information on differentiation from Combination Pack (Combo Pack) and Starter Pack/Patient Initiation Pack:

 

Table XX:

 

No.

Particulars

Convenient Pack

Combination Pack

(Combo Pack)

Starter Pack/ Patient Initiation Pack

1.

New registration number (MAL No.) to be assigned upon approval

No

Yes

No

2.

Mode of application

Variation Type II

Application for registration as a new product

Application for registration as a new product and variation

3.

Purpose of product

For convenience of the consumer

For therapeutic regimen

For dosing regimen

4.

New indication

No

Yes

No

5.

Sale of product

Can be sold individually or as a pack

Only to be sold as a pack

Only to be sold as a pack

6.

Example

Confinement Set or Set Jamu Bersalin

Klacid HP7

(for treatment of peptic ulcer diseases associated with H. pylori infection)

Products that require dose tapering either to reduce systemic side effect or for dose adjustment to achieve the desired maintenance dose

 

 

 

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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