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Veterinary Product Approval & Regulatory Services in South Korea
Veterinary
Veterinary Product Approval Support In South Korea
Artixio is a leading global regulatory consulting company providing the clients with effective strategies and integrated solutions to successfully register and commercialize a product in South Korea market. With a presence in over 120+ countries, we provide complete support throughout the lifecycle of a product.
Overview of the Veterinary Industry in South Korea
In the South Korea, Animal drug industry is an industry of high added values that is expected to show consistent growth. According to the Pharmaceutical Affairs Act and the special provisions under Medical Devices Act, animal drugs and animal medical devices are controlled under the Ministry of Agriculture, Food and Rural Affairs (MAFRA).
Animal medicine in South Korea refers to drugs used only for animals; and it also includes raising bees, silkworm, fishery and pets (including aquarium pets).
The MAFRA operates the laws while the Animal and Plant Quarantine Agency (APQA) gives manufacturing and importing permits, quality control and licensing of Veterinary Medicinal Products and manages safety such as setting up standards, and local governments manage distribution and sales.
The MAFRA or the Minister of Oceans and Fisheries may determine standards for use, such as animals for which such drugs are used, dose regimen, dose, and the period for prohibiting its use.
Full Regulatory Support for Market Entry into South Korea
Artixio’s Compliance & Registration Support in South Korea
- Pre-registration services
- Registration requirements guidance
- Legal representation
- Assistance for import license in South Korea
- GMP Compliance guidance
- Market entry strategies
- Guidance in addressing Health Authority Queries
- Post-Approval Maintenance of the product
Why Choose Artixio for Veterinary Product Approval in South Korea
Regional expertise
Well collaborated with Health Authorities
Global presence
Client focused services
Experts team with experience in successful product commercialization
Strategies to reduce the market entry time of product
ISO 9001:2015 Certified Company
FAQs
What is the Positive List System (PLS) for Veterinary drugs in South Korea?
It is the system introduced to facilitate safety management for veterinary drugs. Under the PLS the uniform limit (0.01mg/kg) applies to domestic and imported livestock and fishery products for which the Maximum Residual Limit (MRL) is not set in Korea. It prevents the import in cases where the safety of veterinary drugs has not been proven.
What post approval services do you provide in South Korea?
Our team provides post approval services to ensure ongoing compliance with the regulations of South Korea including Annual Maintenance, License Renewals, Variation submissions, Labelling updates, ADR reporting, Audit and Inspections support with legal representative agent services.
Do you provide Quality Management Services in South Korea?
Yes, we provide Quality Management Services (QMS) to comply with the regulatory requirements of South Korea.
Our Quality Management Services include
Our Quality Management Services include
- Quality System Assessment & Compliance
- Audit support
- GMP (Good Manufacturing Practice)
- GCP (Good Clinical Practice)
- GPVP (Good Pharmacovigilance Practice)
- Gap Analysis
- 3rd Party Analysis
- Quality System Development
- GXP Training
- GXP Consultation and Support Service
- Operations & Routine QA Support
- SOP Authoring, Review & Harmonization
- CAPA (Corrective and Preventive Actions)
- PQR (Product Quality Review)
- Change Management
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