Guidelines for Application for Registration of Medicinal Products 2006(DRA)

The guidelines outlined in this document are primarily drawn up in accordance to the legal requirements of the Bhutan Medicines Act 2003 and Bhutan Medicines Rules & Regulation 2005.

1.0 DRUG REGISTRATION - Defined in the Art, "Medicinal Products" include
i) All the substances intended for internal or external use of human beings or animals and intended to be used in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals; and
ii) Such substances intended to affect the functioning of any structure found in the human and animal body
iii) Any other substances or device declared by the board to be a medicinal product or a medicine or a drug and this may belong either to modern or traditional system of medicine

-All medicinal products, manufactured, sold, and distributed and imported / exported from Bhutan shall be registered under the provisions of this act.

2.14 Not withstanding the conditions stated above under section 9 of Rules and Regulations, some products may be registered with some exceptions considering the national needs.

2.15 Wherein there is a proof of the product being already registered in a made developed country, appropriate considerations wherever applicable may be in the registration of the products.

2.16 Any person who wishes to import any product for the purpose of research in a school of pharmacy or research or training institution or in order to obtain samples for the purpose of registration, may be exempted from registration with prior approval from the Authority.

2.17 The applicant (if said company is not the product owner) should be authorized in writing by the product owner to be the holder of the product registration certificate and be responsible for all matters pertaining to the registration of the product.

3.0 Responsibility of Marketing Authorization Holder (i.e. the applicant for product registration)

3.1 The applicant shall be responsible for the product and all information supplied in support of his application for registration of the product.

3.2 He shall be responsible for updating any information relevant to the product / application. The DRA should be informed in a timely manner any change in product information during the course of evaluation, and after product registration, especially if the information pertains to refection / withdrawal, additional data on product efficacy and safety or current Good Manufacturing. Practice (cGMP) compliance of the manufacturers.

3.3 The marketing authorization holder must assume responsibility for the quality, safety and efficacy of his products.

4.0 Temporary registration of drugs:
Temporary registration will be granted upon request by relevant government agencies for medicinal products specially required in emergency, disease outbreak and for specific needs of patients.

The application for such registration shall be made in Form VI of Rules & Regulation 2005 with the following documents:
• Therapeutic indication details
• Free sale certificate of the product
• Product registration certificate issued in the country of origin
• Package specification
• Finished product specification

4.1 The registration will be granted in Form IA stamped with an authorised seal indicating so.

4.2 The temporary registration shall be granted for duration of three months at a time with a maximum of six months.

5.0 Fees for registration
The fees for registration of medicinal products shall be as specified in part XXI of the Rules and Regulation and will be subjected to revision from time to time.

Processing fee
Every application for registration shall be accompanied with a processing fee of Nu. 150.00(equivalent to INR 150.00)

Registration fee
The registration fee of Nu. 1500.00 per product shall be paid at the time of issuance of registration certificate.

Temporary registration fee
The temporary registration fee of Nu. 500.00 per product shall be paid at the time of issuance of registration certificate.

Other charges
The Authority may charge any'applicant such costs as it may incur for the purpose of carrying out laboratory investigation if and when necessary prior to registration of the product

5.1 Any payment made is not refundable once an application has been submitted and payment confirmed. Applications without the correct fees will not be processed.

5.2 Multiple Applications
A separate application is required for each product i.e. products containing the same ingredients but made to different specifications (in terms of strength/content of ingredients), dosage form, description, etc.) or by a different manufacturer shall require separate applications for product registration.

6. 0 Processing of applications
Initiation of Review
Review of applications will follow a queue system.

Priority review may be granted where the product is intended for treatment of a serious or life-threatening disease(Fast track registration).

Stop Clock
The clock starts once payment has been confirmed for a submitted application and will stop whenever the DRA needs to seek further information from the applicant. The clock restarts when the DCA receives complete responses from the applicant. A period of 3 months will be given within which the applicant should submit the additional information/clarification required for each correspondence from the DRA.

The clock stops when the DRA informs the applicant of its regulatory decision.

An application will be closed if the stop-clock (i.e. the time taken by the applicant to respond to enquiries) exceeds the 3 months given, and a new application will need to be submitted if the applicant wishes to pursue registration for the product in question.

7.0 Renewal of registration

7.1 Application for renewal shall be made before three months from the date of expiry of registration.

7.2 A grace period shall extend to one month after the specified expiry date.

7.3 Defaulter shall pay a penalty of Nu. 100 per day after the expiry of grace period up to one month.

8.0 Cancellation of registration
The Authority shall cancel the registration of the product if:

8.1 Any of the conditions of registration of the product has been contravened or changed, or

8.2 Any report on adverse drugs reactions of serious nature have been received from National Pharmacovigilance Centre or any other national or international sources, or

8.3 Defaulting of timely renewal beyond one month after grace period, or

8.4 For any other matters as specified, by the Board at the time of cancellation.

9.0 Award of registration certificate

9.1 The registration certificate shall be issued in Form IA of Rules & Regulation.

9.2 The registration certificate may be issued within 30 days from the date of receipt of complete documents unless otherwise a longer period is required in case of which the party will be notified.

The time-frame for registration for all categories of products excludes stop-clock time.

9.3 Rejection, Cancellation, Suspension of Registration
The Bhutan Medicines Board may reject, cancel or suspend the registration of any product if there are deficiencies in safety, quality or efficacy of the product or failure to comply with conditions of registration. Such products may not be imported, manufactured, sold, supplied or possessed for sale.

9.4 Change in particulars of registered products
No change in product name, product specifications, packing, indications, contents of product label, package insert, or product literature, or any relevant particulars of the registered product shall be made wdthout the prior approval of the DRA.

The registration of a product may be cancelled if changes are made without the prior approval of the DRA.

Any change which affects the composition or characteristics of the product such as colour/shade, flavour/fragrance, shape, change of vehicle (liquid preparation) shall require a new application for registration.

9.5 Other information
Criteria for registration
The DRA will register a product only once.

A product will be registered only if it satisfies ALL requirements of the DRA, especially with respect to safety, efficacy and quality of the product.

Other criteria that may be taken into consideration include:
i. Either that the product is needed or not. Aspects like
potential for abuse, number of registered products, different dosage form, etc are considered;
ii. Therapeutic advantage.

Variants for a Given Product
When variants are registered they should only differ in terms of colour and fragrance/flavour as the case may be. The product name shall remain the same, with the addition of an identifying variant name. Each variant will be registered as one (1) product with a different registration number.

Combination Packs
Products which are packed together in combination for a therapeutic regimen (example for the treatment of Helicobacter Pylori, Hepatitis C, etc.) will be classified as a Combination Pack Product and shall be registered as a single product.A product which is packed together with diluenl(s) is not considered as Combination Pack Product.

Product Labelling is required in cither English or Pzongkhamational) And includes the following information:
1. Name product
2. Name and address of manufacturer and marketing authorization holder
3. Batch No. of the combination pack product
4. Expiry date
5. Storage conditions