4.3 : Amendment to the particulars of the product
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20 : AMENDMENTS TO PARTICULARS OF A REGISTERED PRODUCT
Throughout the life cycle of a registered product, changes to improve product efficacy, quality and safety are likely to occur. Therefore, the applicant shall inform the Authority of any changes or amendments made to particulars of a registered product.
20.1 : VARIATION
a) Variation refers to the change of particulars of a registered product. No change of any particulars of a registered product [except for Minor Variation Notification (MiV-N)] shall be made without prior approval from NPRA.
b) All supporting documents shall be submitted in accordance with the specified conditions for each type of variation.
c) Variation applications and processing fees shall be made according to specific product categories in the Malaysian Variation Guideline (MVG).
d) If deemed necessary, NPRA reserves the right to request for additional supporting documents and variation approval letters from other regulatory bodies for all product categories.
e) The registration of a product shall be reviewed for suspension or cancellation if changes that fall under Major Variation (MaV) and Minor Variation Prior Approval (MiV-PA) are implemented without prior approval of the Authority.
f) Variation application shall be submitted through the online QUEST system.
For More Detail on Variation :
Variation Application For Pharmaceutical Products
20.2 : Change Of Manufacturing Site (COS) Application
Refer to Appendix 30: Change of Manufacturing Site (COS).
20.3 Change Of Product Registration Holder
This refers to a transfer of marketing authorization from the existing PRH to another proposed new holder. This change application allows for the same registration number of the registered product to be maintained. Refer to Appendix 31: Change of Product Registration Holder.
20.4 NEW/ ADDITIONAL INDICATION
New/ additional indication is defined as an indication not initially approved for a registered pharmaceutical product. This may include new therapeutic indication or indication for new age group, such as usage in children. This does not include changing/ rephrasing of sentences.
Two (2) types of evaluation processes are available for a new/ additional indication application:
a) Full Evaluation Process
This applies to a new indication that has been registered in any one (1) of the eight (8) DCA’s reference countries (United Kingdom, Sweden, France, United States of America, Australia, Canada, Japan and Switzerland).
This application will require comments from relevant specialists.
b) Verification Process
This applies to a new indication that has been registered in any two (2) DCA’s reference countries (United Kingdom, Sweden, France, United States of America, Australia, Canada, Japan, Switzerland and EMA).
Note: The proposed new indication shall be the same as the approved new indication in the reference countries.
An application to add a new indication deemed not feasible for submission to DCA’s reference agencies may be considered for evaluation by NPRA on a case-by-case basis.
Other supporting documents deemed necessary shall be submitted upon request to support the efficacy and safety of the proposed additional indication.
The supporting documents may include but are 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 Benefit-Risk Evaluation Report (PBRER)
20.5 APPLICATION FOR A CONVENIENT PACK
a) Convenient pack refers to registered products packed together in a single packaging unit for consumers, such as a confinement set or set jamu bersalin.
b) Individually 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 category 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 Abridged Evaluation category)
d) Individually registered products in the convenient pack can be sold individually or as a pack.
e) Conditions for application:
(i) Individually 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.
(iv) Application shall be made via variation application.
(v) The PRH is required to submit the convenient pack label and the individual labels via application for variation under Part D2 (outer label).
(vi) The convenient pack label shall contain the same information as in the primary label.
(vii) Approved indication of each individually registered product in the convenient pack remains unchanged. There shall be no common specific indication for the convenient pack.
f) Labelling requirement specific for the convenient pack:
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Outer Label |
Immediate Label |
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Contents in the labelling of each individually registered product have to be included in the outer label of the convenient pack. |
As per labelling requirements for registered products.
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Note:
For the purpose of application submission: If the individually registered products are also marketed independently, both the outer label of the packaging sold independently and the outer label of the convenient pack are required to be submitted.
g) The differences in a Convenient Pack from a Combination Pack (Combo Pack) and Starter Pack/ Patient Initiation Pack/ Dose Adjustment Pack are as follows:
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No. |
Particulars |
Convenient Pack |
Combination Pack (Combo Pack) |
Starter Pack/ Patient Initiation Pack/ Dose Adjustment Pack |
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1. |
New registration number (MAL No.) to be assigned upon approval |
No |
Yes |
No |
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2. |
Mode of application |
Variation Type II |
Application for registration as a new product |
Application for registration as a new product and variation |
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3. |
Purpose of product |
For convenience of the consumer |
For therapeutic regimen |
For dosing regimen |
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4. |
New indication |
No |
Yes |
No |
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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 |
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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 |
