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YOU ARE HERE: Home Agriculture, Livestock & Fisheries Agriculture, Livestock & Fisheries Development 15.Registration of Veterinary pharmaceuticals
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15.Registration of Veterinary pharmaceuticals

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Requirement:In terms of the sections no.16 and 18 of the Animal Disease Act no.59 of 1992, the veterinary pharmaceutical and biological product (e.g.: vaccines) manufacturers and importers should register their manufactured or imported products for local sale, at the Veterinary Drug Controlling Authority (VDCA) of the Department of Animal Production and Health (DAPH).

Applications are available:

  • www.daph.gov.lk-VDCA
  • Veterinary Regulatory Affairs Division, Department of Animal Production and Health, Peradeniya.

Fee for the application:

The application will be issued free of charge. Nevertheless, it is recommended to follow website information compiled for the registration prepared according to the regulations pertaining to the pharmaceutical product and this document also provides instructions on filling the application and furnishing the requirements which should be completed with the application.

Required certificates: Indicated in the website

 

Time of submission:

From 8.30 a.m to 4.15 p.m during the office hours on weekdays on pre-arranged appointment basis. Appointments can be booked over the phone No:0812384546 or email: vdca.daph@gmail.com

 

Types of Licenses issued by VDCA

Local manufacture or repacking of veterinary pharmaceutical and biological products

Free sale of locally manufactured or repacked veterinary pharmaceutical and biological products

Export of locally manufactured or repacked veterinary pharmaceutical and biological products

Import of veterinary pharmaceutical and biological products for free sale

User Permits-Import of veterinary pharmaceutical and biological products for specific requirements- of owned farms, veterinary institutions or veterinarians- (Under this category, a user permit can be obtained to import and use a veterinary pharmaceutical or biological product (e.g.: vaccines) which are not locally registered. User permit is valid for a limited duration and usually for 6 months. For farm requirements, relevant application must be submitted with the recommendation of Divisional Veterinary Surgeon and District Veterinary Investigation Officer of the area and a veterinarian can directly make such application in the relevant format. (The application fee SLR 1000/=)

 

 

 

Service/Application charges:

No

Service

Current fee (LKR)

1

Import and free sale registration (Per product)

-          Dossier submission

-          Free sales Certificate

 

3,000.00

2,000.00

2

Manufacture or Re-packing  License (Per product)

-          Dossier submission

-          Manufacture/ Re-packing License

 

-

2,000.00

3

Renewal of Licenses for Import and free sale (Per product)

-          Dossier submission

-          Renewal Certificate

 

-

2,000.00

4

Renewal of Licenses-for Manufacture/Re-packing

-          Dossier submission

-          Renewal Certificate

 

-

1,000.00

5

Issue of User Permit (for Individual/Farm/Clinical settings/Veterinarians)

-          Application submission fee

-          User Permit

 

 

1,000.00

-

 

 

Time duration for the provision of the service: from 02 weeks to 03 months

Staff Officers in charge of the services:

Designation

Name

Unit

contact No.

Fax

E-mail

Registrar/Veterinary Drugs

Dr.M.D.N.Jayaweera

VDCA

Organization Information

Department of Animal Production and Health

Department of Animal Production and Health
P.O.Box 13,
Peradeniya
Sri Lanka


Dr.S.S.P. Silva
Telephones:+94 81 2388195
Fax Nos:+94 81 2388619
Email:
Website: www.daph.gov.lk

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Last Updated On: 2020-08-14 07:11:49
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