Guidelines for the Control of Aquaculture Medicinal Products
Type:
Instruction
Issuing Agency:
Ministry of Fisheries and Livestock
Responsible Agency:
Ministry of Fisheries and Livestock
Issuing Date:
01-01-2015
Guidelines for the Control of Aquaculture Medicinal Products-AMPs
Table of Contents
1. Objectives and Scope ....................................................................................................................3
2. Legal background ...........................................................................................................................3
3. Definitions and Abbreviations .........................................................................................................5
4. Roles and Responsibilities .............................................................................................................7
5. Guidelines for the Control of Aquamedicines .................................................................................8
6. Guidelines for Field Monitoring of Aquarnedicines .......................................................................13
7. Implementation oftlte Guidelines and Coordination of the Aquamedieine Control Program..........14
8. Validity of the Guidelines ...............................................................................................................15
1. Objectives and Scope
The overall objective of this Guidelines is to ensure that Aquaculture Medicinal Products (herein after relfered as Aquamedicines or AMPS) produced in or imported to Bangladesh used for the production of fish and fishery products are leading to products that are safe for consumers.
The specific objectives of the Guidelines for the control of Aquamedicines arc:
- to control the use of aquamcdicincs across the production chain of aquaculture
operations.
- to ensure that the exposure of aquatic animals to aquamedicines does not pose a
risk to human health.
- to ensure that the aquaculture products produced in Bangladesh comply with the
maximum residue limits (MRLs) for permitted substances.
- to prevent illegal or unauthorized use of aquamedicines
- to monitor and verify that appropriate practices are being applied and effective
measures are in place at manufacture. import. distribution. retailing. and use.
This Guidelines is intended to provide the guidance on registration, manufacture, import, distribution, retailing. and use of Aquamedicincs to be followed by regulatory agencies, manufacturers. importers. wholesalers. retailers. fisheries professionals. and users.
This Guidelines may periodically undergo further refinement to comply with the current national and intemational requirements.
2. Legal background
This Guideline is based on the legislative framework of Bangladesh related to drugs as well as those of international guidelines pertaining to Aquaculture Medicinal Products and more specific regulations for aquaculture.
Drug related Rules of Bangladesh
- The DRUGS ACT, I940 (XXIII OF I940).
- The Bengal Drugs Rules. I946 (As amended by the Government of East Bengal up
to December I952).
- The Drugs (Control) Ordinance. I982. Ordinance No. Vlll of I982; It is an ordinance to control manufacture. import. distribution and sale of drugs.
National Drug Policy 2005.
Fish and Fishery related Rules of Bangladesh
- Fish and Fish Products (Inspection and Quaiity Control) Ordinance. I983
- Fish and Fish Products (Inspection and Quality Control) Rule I997 (amendment 2008)
- Fish llatchery Act 20l0
- Monitoring of resistance to identify emerging health problems and planning of
timely corrective actions to protect human health and.
- Guidelines for professionals to reduce overuse and misuse of antimicrobials in
food animals.
3. Definitions and Abbreviations
a) Aquaculture Medicinal Products- AMPs (Aquamedieines)
Aquaculture Medicinal Products (herein after referred to as
Aquamedicines) means Medicinal Products used in aquaculture or
any substance or combination of substances presented as having
properties for treating or preventing disease in aquatic animals; or any
substance or combination of substances which may be used in or
administered to aquatic animals with a view either to restoring.
correcting or modifying physiological functions by exerting a
pharmacological. immunological or metabolic action. or to making a
medical diagnosis“ (Definition for VMPs in Directive 200I/82/EC).
In the context of this Guidelines. the term “Aquamedicine” shall
mean: “medicine and medicinal products used in aquaculture
including those used in activities such as farm. hatchery and Fish feed mills .
b) Aquatic animals
Aquatic animals means all life stages (including egg and gametes) of
fish. molluscs and crustaceans originating from aquaculture
establishments or removed from the wild. for farming purposes. for
release into the environment. for human consumption or for ornamental purposes.
c) CCC
CCC means Central Coordination Committee constituted of
representatives of DGDA. Department of Fisheries and relevant
experts Director General of DGDA will decide the number of CCC
members. CCC may include one or the frslrerics aeademieian as
expert member from any University in its committee CCC may make recommendations
related to withdrawal periods. area of use or application. target species. etc based on the
relevant rules.
d) DCC
DCC means Dnrg Control Committee as per definition of “The Drugs
(Control) Ordinance”. I982. No. 4
e) DGDA
DGDA means Directorate General of Drug Administration. whch is
the Drug Regulatory and Control Agency of Bangladesh
f) DoF
DoF means Department of Fisheries of Bangladesh
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