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Template/Guide for Product Information (PI) for Generic Products

  • Background

    • The registration process of a generic product requires an application that encompasses Part I (Administrative Data and Product Information) and Part II (Quality) information.
    • Section A of Part I involves product particulars that will be translated into the package insert (PI) which is part of Section D.
    • According to the ASEAN Glossary used in the ASEAN Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR), a package insert is a document defining information that are supplied with a pharmaceutical product by the marketing authorization holder (MAH).
    • Package inserts are required for products classified as Scheduled Poisons and they may also be submitted for Non Poisons (Over the Counter, OTC) products.
    • The draft copy of the package insert should be submitted for evaluation as it is a criteria to be fulfilled during the product registration process. The information furnished in the package insert must be identical to the information submitted in Section A of the application form.
    • During online applications for generic products, product information submitted by applicants (Section A and package insert) is sometimes inconsistent and there are variations between generic products and also with the innovator product.
    • The time for evaluation is affected as evaluators not only have to evaluate the information submitted in both sections but even correct grammatical errors and spelling mistakes.
    • For applicants on the other hand, many find it difficult to submit information based on registered products or relevant information as some references are not up-to-date or are not as approved by the Drug Control Authority (DCA).

    Rationale for providing Template/Guide

    • These templates serve as a guide to applicants on product information based on the information approved for innovator products by the DCA.
    • The product information is general and not based on statistics or clinical trials by the innovator product. Therefore the information in these templates are suitable for generic products.
    • The product information is arranged according to the requirements for package inserts in accordance to the Drug Registration Guidance Document.
    • It will help applicants in submitting/providing product information (Section A and package insert) to ensure consistency in information for all registered generic products.
    • It will also help evaluators and ensure consistency during the evaluation process.
    • Hence, these templates can bridge the gap for both parties and improve the application and the evaluation process.
    • These templates are also furnished with Specific Labeling Requirements for the specific active ingredient (if applicable).

    Implementation

    • The active ingredients for the templates created have been chosen based on the most common applications submitted to DCA and the number of templates will be increased from time to time.
    • The templates are prepared based on information from established references such as Micromedex and Martindale. However the indication is as approved for products registered by DCA
    • Updating of the product information/templates will be carried out if/when there are changes made to the innovator product information in terms of indication, dosage regimen as well as any new policy enforced by DCA.
    • Applicants are advised to use these templates in preparing information for Section A and package insert that is suitable with the dosage form of their products to be registered.
  • No

    Active ingredient

    Template/Guide

    View (PDF)

    1. 

    Acyclovir (4)

    Acyclovir Dispersible Tablet & Oral Suspension

    Acyclovir Cream

    Acyclovir Ophtalmic Ointment

    Acyclovir Powder for IV Infusion

    207 KB

    143 KB

    140 KB

    178 KB

    2. Adapalene (1) Adapalene Cream or Gel 181 KB
    3. Alendronate (1) Alendronate Tablet 190 KB

    4. 

    Amlodipine (1)

    Amlodipine Tablet

    366 KB

    5. Anagrelide Hydrochloride(1) Anagrelide Hydrochloride Capsule 224 KB

    6.

    Anastrozole (1)

    Anastrozole Tablet

    231 KB

    7. Atenolol (1) Atenolol Tablet 354 KB

    8.

    Atorvastatin (1)

    Atorvastatin Tablet

    385 KB

    9. Azelaic Acid (1) Azelaic Acid Cream or Lotion 248 KB

    10.

    Azithromycin (2)

    Azithromycin Tablet & Powder for Oral Suspension

    Azithromycin Powder for IV Solution

    461 KB

    439 KB

    11. Baclofen (1) Baclofen Tablet 346 KB

    12

    Bisoprolol (1)

    Bisoprolol Tablet

    259 KB

    13.

    Captopril (1)

    Captopril Tablet

    282 KB

    14. Carboplatin (1) Carboplatin Solution for Injection 181 KB

    15.

    Carvedilol (1)

    Carvedilol Tablet

    245 KB

    16. Ceftazidime pentahydrate(1) Ceftazidime Powder for solution For Injection/Infusion 380 KB
    17. Ceftriaxone sodium (1) Ceftriaxone Powder for solution For Injection/Infusion 379 KB
    18. Cetirizine hydrochloride (1) Cetirizine Tablet/Oral Drops/Oral Solution 349 KB

    19.

    Cinnarizine (1)

    Cinnarizine Tablet

    171 KB

    20. 

    Ciprofloxacin (2)

    Ciprofloxacin Tablet

    Ciprofloxacin IV Infusion Solution

    267 KB

    335 KB

    21. 

    Clarithromycin (4)

    Clarithromycin Tablet

    Clarithromycin MR Tablet

    Clarithromycin Granules for Oral Suspension

    Clarithromycin Powder for IV Infusion

    204 KB

    222 KB

    222 KB

     

    217 KB

    22. Clomiphene (1) Clomiphene Tablet 191 KB
    23. Clopidogrel hydrogen sulphate/ bisulphate (1) Clopidogrel Tablet 373 KB
    24. Clotrimazole Clotrimazole Vaginal Tablet 140 KB

    25. 

    Diclofenac sodium (5)

    Diclofenac Sodium Enteric Coated Tablet

    Diclofenac Sodium SR Tablet

    Diclofenac Sodium Suppository

    Diclofenac Sodium Solution for Injection

    Diclofenac Sodium Eye Drop

    226 KB

    223 KB

    205 KB

    210 KB

    159 KB

    26. Docetaxel (1) Docetaxel Solution for Injection 227 KB

    27.

    Domperidone (1)

    Domperidone Tablet & Oral Suspension

    186 KB

    28.

    Donepezil (1)

    Donepezil Tablet & Orodispersible Tablet

    192 KB

    29.

    Epirubicin Hydrochloride(1)

    Epirubicin Hydrochloride Intravesical Injection & Intravenous Infusion

    280 KB

    30. Etoricoxib (1) Etoricoxib Tablet 361 KB

    31. 

    Felodipine (1)

    Felodipine ER Tablet

    279 KB

    32. Finasteride (1) Finasteride Tablet 179 KB
    33. Gabapentin (1) Gabapentin Capsule/ Tablet 403 KB

    34.

    Gliclazide (2)

    Gliclazide Tablet

    Gliclazide MR Tablet

    191 KB

    196 KB

    35.

    Glimepiride (1)

    Glimepiride Tablet

    300 KB

    36.

    Granisetron (1)

    Granisetron Tablet & Ampoule For Intravenous Injection / Infusion

    186 KB

    37. Irbesartan (1) Irbesartan Tablet 189 KB
    38. Latanoprost (1) Latanoprost Eye Drop 225 KB

    39.

    Letrozole (1)

    Letrozole Tablet

    198 KB

    40.

    Loperamide Hydrochloride(1)

    Loperamide Hydrochloride Capsule & Tablet

    270 KB

    41.

    Loratadine (2)

    Loratadine Tablet & Syrup

    Loratadine Orodispersible Tablet

    181 KB

    172 KB

    42.

    Meloxicam (1)

    Meloxicam Tablet & Capsule

    202 KB

    43.

    Meropenem (1)

    Meropenem Powder For Intravenous Injection & Infusion

    185 KB

    44. Metformin hydrochloride(2)

    Metformin Tablet

    Metformin Extended Release Tablet

    348 KB

    348 KB

    45.

    Montelukast (1)

    Montelukast Tablet & Chewable Tablet & Granules For Oral Solution/Suspension

    298 KB

    46.

    Olanzapine (2)

    Olanzapine Tablet & Orodispersible Tablet

    Olanzapine Powder for IM Injection

    244 KB

     232 KB

    47.

    Quetiapine (2)

    Quetiapine Tablet

    Quetiapine ER Tablet

    312 KB

    306 KB

    48.

    Ranitidine (2)

    Ranitidine Tablet, Effervescent Tablet, Effervescent Granules & Syrup

    Ranitidine Solution for IV/IM Injection

    181 KB

    161 KB

    49.

    Risperidone (2)

    Risperidone Tablet & Oral Solution

    Risperidone ER Powder for IM Injection

    212 KB

    245 KB

    50.

    Salbutamol (4)

    Salbutamol Injection & Salbutamol Solution For Intravenous Infusion

    Salbutamol Metered Dose Inhaler

    Salbutamol Respirator Solution & Salbutamol Solution For Inhalation

    Salbutamol Tablet & Salbutamol Syrup

    182 KB


    185 KB

    191 KB


    182 KB

    51. Silver Sulphadiazine (1) Silver Sulphadiazine Cream 330 KB

    52.

    Simvastatin (1)

    Simvastatin Tablet

    354 KB

    53. Tamoxifen (1) Tamoxifen Tablet 199 KB
    54. Tibolone (1) Tibolone Tablet 248 KB
    55. Topiramate (1) Topiramate Tablet 212 KB

    56.

    Valsartan (1)

    Valsartan Tablet

    210 KB

    57. Zolpidem (1) Zolpidem Tablet 254 KB
  • No

    Active ingredient

    Template/Guide

    View (PDF)

    1.

    Acetylcysteine (1)

    Acetylcysteine Granules

    164 KB

    2. Acetylsalicylic acid (2)

    Acetylsalicylic acid 100mg dan 300mg enteric coated tablet

    Acetylsalicylic acid 500mg

    109 KB

     106 KB

    3.

    Activated Charcoal (1)

    Activated Charcoal Tablet / Capsule / Granule / Powder

    182 KB

    4.

    Albendazole (1)

    Albendazole Tablet & Suspension

    211 KB

    5.

    Ambroxol (1)

    Ambroxol Tablet / Capsule / Lozenges / Elixir

    187 KB

    6.

    Bisacodyl (1)

    Bisacodyl Tablet & Suppositories

    185 KB

    7.

    Bromhexine (1)

    Bromhexine Tablet & Syrup/Elixir

    170 KB

    8.

    Calamine & Zinc Oxide (1)

    Calamine & Zinc Oxide Cream

    155 KB

    9.

    Calcitriol (2)

    Calcitriol Capsule

    Calcitriol Injection

    201 KB

    179 KB

    10

    Cetrimide (1) Cetrimide Cream & Lotion 30 KB

    11.

    Chlorhexidine Gluconate(1) Chlorhexidine Gluconate 16 KB

    12.

    Clotrimazole (1)

    Clotrimazole Cream / Lotion /   Solution/ Dusting Powder

    170 KB

    13.

    Glucosamine(1)

    Glucosamine Tablet/Capsule/

    Sachet /Granules for Oral Solution

    164 KB

    14. Lactulose (1) Lactulose 94 KB

    15.

    Menthol & Camphor & Methyl salicylate (1)

    Menthol & Camphor & Methyl salicylate Cream/ Ointment/ Liniment

    178 KB

    16 Oral Rehydration Salt (1) Oral Rehydration Salt 50 KB

    17.

    Paracetamol (3)

    Paracetamol  Tablet

    Paracetamol  Oral Suspension/Syrup

    Paracetamol  Suppositories

    213 KB

    205 KB

    212 KB

    18.

    Paracetamol and Caffeine(1) Paracetamol and caffeine Tablet 22.6 KB

    19.

    Simethicone (1)

    Simethicone Tablet/Capsule

    170 KB

    20.

    Sodium Chloride (1)

    Sodium Chloride  0.9% w/v for IV Infusion

    175 KB

    21.

    Terbinafine (1)

    Terbinafine Cream / Gel

    174 KB

    22.

    Water For Injection (1)

    Water For Injection

     

    157 KB

    23. Guaiphenesin / Guaicol Glycerol Ether (1)

    Guaiphenesin / Guaicol Glycerol Ether Tablet/ Capsule/ Syrup

     

    30KB
    24. Mecobalamine (2)

    Mecobalamine Tablet & Capsule

    Mecobalamin Injection

    70KB

    150 KB

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