- Information
- Scheduled Poisons
- Non Poisons (OTC)
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
2. Adapalene (1) Adapalene Cream or Gel 181 KB 3. Alendronate (1) Alendronate Tablet 190 KB 4.
Amlodipine (1)
Amlodipine Tablet
5. Anagrelide Hydrochloride(1) Anagrelide Hydrochloride Capsule 224 KB 6.
Anastrozole (1)
Anastrozole Tablet
7. Atenolol (1) Atenolol Tablet 354 KB 8.
Atorvastatin (1)
Atorvastatin Tablet
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
11. Baclofen (1) Baclofen Tablet 346 KB 12
Bisoprolol (1)
Bisoprolol Tablet
13.
Captopril (1)
Captopril Tablet
14. Carboplatin (1) Carboplatin Solution for Injection 181 KB 15.
Carvedilol (1)
Carvedilol Tablet
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
20.
Ciprofloxacin (2)
Ciprofloxacin Tablet
Ciprofloxacin IV Infusion Solution
21.
Clarithromycin (4)
Clarithromycin Tablet
Clarithromycin MR Tablet
Clarithromycin Granules for Oral Suspension
Clarithromycin Powder for IV Infusion
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
26. Docetaxel (1) Docetaxel Solution for Injection 227 KB 27.
Domperidone (1)
Domperidone Tablet & Oral Suspension
28.
Donepezil (1)
Donepezil Tablet & Orodispersible Tablet
29.
Epirubicin Hydrochloride(1)
Epirubicin Hydrochloride Intravesical Injection & Intravenous Infusion
30. Etoricoxib (1) Etoricoxib Tablet 361 KB 31.
Felodipine (1)
Felodipine ER Tablet
32. Finasteride (1) Finasteride Tablet 179 KB 33. Gabapentin (1) Gabapentin Capsule/ Tablet 403 KB 34.
Gliclazide (2)
Gliclazide Tablet
Gliclazide MR Tablet
35.
Glimepiride (1)
Glimepiride Tablet
36.
Granisetron (1)
Granisetron Tablet & Ampoule For Intravenous Injection / Infusion
37. Irbesartan (1) Irbesartan Tablet 189 KB 38. Latanoprost (1) Latanoprost Eye Drop 225 KB 39.
Letrozole (1)
Letrozole Tablet
40. Loperamide Hydrochloride(1)
Loperamide Hydrochloride Capsule & Tablet
41.
Loratadine (2)
Loratadine Tablet & Syrup
Loratadine Orodispersible Tablet
42.
Meloxicam (1)
Meloxicam Tablet & Capsule
43.
Meropenem (1)
Meropenem Powder For Intravenous Injection & Infusion
44. Metformin hydrochloride(2) Metformin Tablet
Metformin Extended Release Tablet
45.
Montelukast (1)
Montelukast Tablet & Chewable Tablet & Granules For Oral Solution/Suspension
46.
Olanzapine (2)
Olanzapine Tablet & Orodispersible Tablet
Olanzapine Powder for IM Injection
47.
Quetiapine (2)
Quetiapine Tablet
Quetiapine ER Tablet
48.
Ranitidine (2)
Ranitidine Tablet, Effervescent Tablet, Effervescent Granules & Syrup
Ranitidine Solution for IV/IM Injection
49.
Risperidone (2)
Risperidone Tablet & Oral Solution
Risperidone ER Powder for IM Injection
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
51. Silver Sulphadiazine (1) Silver Sulphadiazine Cream 330 KB 52.
Simvastatin (1)
Simvastatin Tablet
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
57. Zolpidem (1) Zolpidem Tablet 254 KB No
Active ingredient
Template/Guide
View (PDF)
1.
Acetylcysteine (1)
Acetylcysteine Granules
2. Acetylsalicylic acid (2) Acetylsalicylic acid 100mg dan 300mg enteric coated tablet
Acetylsalicylic acid 500mg
3.
Activated Charcoal (1)
Activated Charcoal Tablet / Capsule / Granule / Powder
4.
Albendazole (1)
Albendazole Tablet & Suspension
5.
Ambroxol (1)
Ambroxol Tablet / Capsule / Lozenges / Elixir
6.
Bisacodyl (1)
Bisacodyl Tablet & Suppositories
7.
Bromhexine (1)
Bromhexine Tablet & Syrup/Elixir
8.
Calamine & Zinc Oxide (1)
Calamine & Zinc Oxide Cream
9.
Calcitriol (2)
Calcitriol Capsule
Calcitriol Injection
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
13.
Glucosamine(1)
Glucosamine Tablet/Capsule/
Sachet /Granules for Oral Solution
14. Lactulose (1) Lactulose 94 KB 15.
Menthol & Camphor & Methyl salicylate (1)
Menthol & Camphor & Methyl salicylate Cream/ Ointment/ Liniment
16 Oral Rehydration Salt (1) Oral Rehydration Salt 50 KB 17.
Paracetamol (3)
Paracetamol Tablet
Paracetamol Oral Suspension/Syrup
Paracetamol Suppositories
18.
Paracetamol and Caffeine(1) Paracetamol and caffeine Tablet 22.6 KB 19.
Simethicone (1)
Simethicone Tablet/Capsule
20.
Sodium Chloride (1)
Sodium Chloride 0.9% w/v for IV Infusion
21.
Terbinafine (1)
Terbinafine Cream / Gel
22.
Water For Injection (1)
Water For Injection
23. Guaiphenesin / Guaicol Glycerol Ether (1) Guaiphenesin / Guaicol Glycerol Ether Tablet/ Capsule/ Syrup
30KB 24. Mecobalamine (2) Mecobalamine Tablet & Capsule
Mecobalamin Injection
