Best FDA Law Lawyers in Sri Lanka

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John Wilson Partners
Colombo, Sri Lanka

Founded in 1920
12 people in their team
Afrikaans
English
French
Sinhala
Tamil
Swedish
Business FDA Law Employer +4 more
ABOUT US: Founded in 1920 by the late Senator John Wilson, the firm is an established legal practice in Sri Lanka, providing service in the areas of civil litigation, commercial law and notarial practice to corporations, financial institutions and individuals. John Wilson Partners has an...
Layards and Stuart
Colombo, Sri Lanka

Founded in 2000
50 people in their team
Sinhala
Tamil
English
Who we are and how we workLayards & Stuart is a law firm based in Colombo, Sri Lanka providing quality legal advice, solutions and representation to both local and international corporate clients. Our experience in cross-border and emerging economies gives us the market perspective to be your...

Founded in 2000
50 people in their team
Sinhala
English
Tamil
ABOUT CCCSCCCS is the Corporate Secretarial and Investment facilitation arm of Tiruchelvam Associates which is one of the leading law firms in Sri Lanka. The Company services an Impressive portfolio of local and international clientele and has recently completed 25 years of distinction in providing...
A WIJESINGHE CHAMBERS
Colombo, Sri Lanka

Founded in 2008
5 people in their team
English
Sinhala
Tamil
We are a professional team offering a broad range of services tailored to both businesses and individuals. Our expertise spans legal, corporate, and advisory areas, ensuring that clients receive comprehensive solutions suited to their unique needs. Specializing in company secretarial services,...
Qanunie Consultants
Colombo, Sri Lanka

Founded in 2021
4 people in their team
English
Sinhala
Who We Are: Qanunie Consultants offer a multitude of legal services covering a wide scope ranging from legal consultancy, contracts management, company secretarial, conveyancing to civil and corporate litigation as well as HRM and business administration. Comprising a team of highly qualified...
Legante

Legante

30 minutes Free Consultation
Colombo, Sri Lanka

Founded in 2024
6 people in their team
English
Tamil
Sinhala
Legante is a progressive full-service law firm in Sri Lanka, offering strategic legal solutions in intellectual property, commercial law, labor law, dispute resolution, regulatory compliance, and cross-border investment advisory, with a strong international outlook. Please visit our website;...
Continental Law AssocIates
Colombo, Sri Lanka

Founded in 2000
50 people in their team
Sinhala
English
Tamil
ABOUT USEstablished in the year 2000, we take pride in our nearly two decades long legal practice providing feasible solutions to the legal needs of clients in a multitude of areas. The firm has had hands on experience, specializing in Commercial Law, Local and International Arbitration, Civil Law...
Gregory's Partners
Colombo, Sri Lanka

Founded in 1970
200 people in their team
Sinhala
English
Tamil
AboutThe Sri Lankan economy and therefore its legal system has traditionally been influenced by the island’s colonial past. Thus, the legal profession in Sri Lanka was traditionally divided into two fractions based on functionality influenced by a similar divide in the English Legal system.The...
Neelakandan & Neelakandan
Colombo, Sri Lanka

Founded in 1962
200 people in their team
Sinhala
English
Neelakandan & Neelakandan (formerly Murugesu & Neelakandan) is one of the leading and oldest full-service law firms in Sri Lanka and has been in practice for almost 60 years.The Firm was founded in 1962 by the late Mr. Velupillai Murugesu, and built to be recognised as one of the most...
F J & G de Saram
Colombo, Sri Lanka

Founded in 1841
200 people in their team
Sinhala
Tamil
English
The FirmHistoryF. J. & G. de Saram is the oldest law firm in Sri Lanka.The practice was commenced in 1841 by F. J. de Saram. Snr., the same year in which the overland emigration to California began by wagon trail. Melbourne in Australia was founded only six years before that.In Sri Lanka those...
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About FDA Law in Sri Lanka

FDA Law in Sri Lanka refers to the legal framework governing the regulation, control, import, export, manufacture, and sale of food, drugs, cosmetics, and medical devices. The term FDA commonly denotes the Food and Drug Act, primarily governed by the Food Act No. 26 of 1980 and the Cosmetics, Devices and Drugs Act No. 27 of 1980 along with their amendments and associated regulations. The aim is to ensure the safety, quality, and efficacy of consumable products intended for human use in the Sri Lankan market.

Why You May Need a Lawyer

There are several scenarios where legal assistance in the field of FDA Law is advisable in Sri Lanka. Common situations include:

  • Importing food, drug, cosmetic, or medical device products and obtaining the necessary approvals
  • Addressing non-compliance allegations or defending against regulatory enforcement actions by authorities
  • Registering a new drug, medical device, or cosmetic with the relevant authorities
  • Navigating product recalls, labeling disputes, and advertising approvals
  • Representing companies or individuals in cases of alleged adulteration or misbranding
  • Advising on licensing, permits, and renewals for manufacturers, importers, or distributors
  • Assisting with the investigation of consumer complaints and regulatory audits

Local Laws Overview

The primary legislation governing food, drugs, cosmetics, and medical devices in Sri Lanka is as follows:

  • Food Act No. 26 of 1980 regulates the manufacture, importation, sale, and labeling of food items to ensure safety and hygiene.
  • Cosmetics, Devices and Drugs Act No. 27 of 1980 governs the registration, licensing, import, export, and quality control of drugs, medical devices, and cosmetics.
  • Regulations and Amendments specify detailed requirements for labeling, product standards, prohibited substances, and registration procedures for different product categories.
  • Regulatory Authorities such as the Ministry of Health, National Medicines Regulatory Authority (NMRA), and Food Control Administration Unit are responsible for monitoring and enforcement under these laws.
  • Strict penalties apply for violations, including product seizure, cancellation of licenses, fines, and even imprisonment in severe cases.

Frequently Asked Questions

What is the role of the Food and Drug Authority in Sri Lanka?

The key agencies are the Food Control Administration Unit and NMRA, responsible for regulating and monitoring food, drugs, cosmetics, and medical devices to ensure public health and consumer safety.

Do I need a license to import food or drugs into Sri Lanka?

Yes, you must obtain the relevant licenses and approvals from the appropriate authorities before importing food, drugs, cosmetics, or medical devices into Sri Lanka.

How does the product registration process work?

Manufacturers and importers must submit applications with supporting documentation, fees, and samples as per the relevant guidelines to the regulatory body. The product will be assessed for safety, quality, and efficacy before registration is granted.

What are the labeling requirements for food and drug products?

Labels must accurately display information such as product name, manufacturer, ingredients, expiry date, storage instructions, and any mandatory warnings as per Sri Lankan regulations.

Can I advertise my food, drug, or cosmetic product freely?

Advertising of such products is strictly regulated. Claims must be truthful and approved by authorities, especially for medical, nutritional, or therapeutic claims.

What happens if my product is found to be non-compliant?

Non-compliant products risk being seized, recalled, or banned from sale. The responsible party may face legal action, fines, and possible imprisonment.

How are product recalls managed in Sri Lanka?

Product recalls are typically coordinated by regulatory bodies, and affected businesses are required to cooperate fully, notify consumers, and remove products from the market promptly to minimize public health risks.

What should I do if I receive a notice from a regulatory authority?

Contact a lawyer experienced in FDA Law to review the notice, understand your obligations, and formulate an appropriate response or defense.

Are there specific quality standards for imported products?

Yes, imported products must comply with Sri Lankan standards and may be subject to testing or certification before being approved for sale.

Can individuals file complaints about unsafe or non-compliant products?

Yes, consumers and other parties can submit complaints to the Food Control Administration Unit, NMRA, or public health authorities for investigation.

Additional Resources

You can contact or consult the following bodies and organizations for information or guidance relating to FDA Law in Sri Lanka:

  • Ministry of Health - Food Control Administration Unit
  • National Medicines Regulatory Authority (NMRA)
  • Consumer Affairs Authority
  • Government Analyst's Department
  • Sri Lanka Standards Institution (SLSI)
  • Chamber of Commerce and professional legal associations specializing in health and FDA Law

Next Steps

If you require legal assistance in FDA Law in Sri Lanka, here are suggested steps:

  • Identify the specific issue or concern related to your product or business
  • Gather all relevant documents, licenses, and correspondence with authorities
  • Consult a qualified lawyer with expertise in FDA Law and relevant local regulations
  • Follow your lawyer's advice regarding compliance, documentation, and any required legal responses
  • Stay updated on regulatory changes and maintain ongoing compliance to avoid future legal complications

Legal advice tailored to your specific situation is crucial in FDA Law matters to protect your interests, assure compliance, and minimize risk.

Lawzana helps you find the best lawyers and law firms in Sri Lanka through a curated and pre-screened list of qualified legal professionals. Our platform offers rankings and detailed profiles of attorneys and law firms, allowing you to compare based on practice areas, including FDA Law, experience, and client feedback. Each profile includes a description of the firm's areas of practice, client reviews, team members and partners, year of establishment, spoken languages, office locations, contact information, social media presence, and any published articles or resources. Most firms on our platform speak English and are experienced in both local and international legal matters. Get a quote from top-rated law firms in Sri Lanka - quickly, securely, and without unnecessary hassle.

Disclaimer:
The information provided on this page is for general informational purposes only and does not constitute legal advice. While we strive to ensure the accuracy and relevance of the content, legal information may change over time, and interpretations of the law can vary. You should always consult with a qualified legal professional for advice specific to your situation. We disclaim all liability for actions taken or not taken based on the content of this page. If you believe any information is incorrect or outdated, please contact us, and we will review and update it where appropriate.