Best FDA Law Lawyers in Colombo

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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...
Premier Legal Consultants
Colombo, Sri Lanka

Founded in 2000
50 people in their team
Sinhala
English
Tamil
Premier Legal Consultants is a law firm established in Sri Lanka. Our team of lawyers are committed in providing high quality and timely legal services to our clients. We provide a range of legal services for both local and international clients.Premier Legal Consultants is a law firm established...
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...
Melgate International (Pvt) Ltd
Colombo, Sri Lanka

Founded in 2000
50 people in their team
Sinhala
English
Tamil
WELCOME TO MELGATEWORK WITH IMMIGRATION ATTORNEYS & LEGAL EXPERTSMelgate is a specialized Immigration Law firm providing a full range of immigration services in your quest to migrate Canada, Australia, NZ, UK, USA or EU countries temporary or permanently and the firm has a global reach in vary...
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;...
Iconic Partners Private Limited
Colombo, Sri Lanka

Founded in 2000
50 people in their team
Sinhala
English
Tamil
About Iconic PartnersICONIC PARTNERS, reputed among the handful of Legal Consultancy and Business Advisory firms in Sri Lanka functions in the Heart of Colombo with the objective of achieving the foremost rank in the fields of Litigation Consultancy Services and Corporate Advisory Services.The firm...
TRIVE LEGAL ASSOCIATES
Colombo, Sri Lanka

Founded in 2000
50 people in their team
Sinhala
English
Tamil
OverviewRanging from the work of an Instructing Attorney to fully fledged Counsel in the Courts of First Instance, Appellate Courts and any other for a. We also facilitate mediations, arbitrations, negotiations, settlementWe specialize in Company Law, Commercial Law, Intellectual Property, Shipping...
ATD Legal Associates

ATD Legal Associates

1 hour Free Consultation
Colombo, Sri Lanka

Founded in 1976
10 people in their team
English
Sinhala
Chinese
 Welcome to ATD Legal Associates Innovative Legal Solutions for a Digital and Global EraAt ATD Legal Associate  we specialize in navigating the complexities of modern legal landscapes. From safeguarding your intellectual property to ensuring compliance with international data privacy...
Macon Associates
Colombo, Sri Lanka

Founded in 2000
50 people in their team
Sinhala
English
Tamil
ABOUT MACONSWHO WE AREMacon Associates specialize in providing total corporate and legal solutions to individuals and businesses. We are committed to maintaining integrity and ethical dealings while protecting your interests.Our philosophy is to provide cost-effective and timely solutions, while...
SSKM Attorneys

SSKM Attorneys

15 minutes Free Consultation
Colombo, Sri Lanka

Founded in 2012
15 people in their team
Sinhala
Tamil
English
SSKM Attorneys was established with the goal of delivering a modern and responsive service for a changing world. The law firm is led by a team of highly qualified, versatile lawyers with extensive knowledge and multidisciplinary experience in both international and local contexts.By working with...
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About FDA Law in Colombo, Sri Lanka

FDA Law in Colombo, Sri Lanka refers to the body of laws, regulations, and guidelines that oversee the safety, manufacturing, importation, distribution, and sale of food, drugs, and related products. It is designed to protect public health by ensuring that products consumed or used by the public are safe, effective, and properly labeled. The National Medicines Regulatory Authority (NMRA) and the Food Control Administration Unit under the Ministry of Health are the key regulators in Sri Lanka, handling oversight and enforcement responsibilities. FDA Law also includes provisions relating to cosmetics and medical devices, offering a comprehensive framework for regulating products that impact human health in Colombo and across the country.

Why You May Need a Lawyer

Engaging a lawyer experienced in FDA Law can be crucial in several circumstances. If you are a business seeking to enter the market with a new food product, drug, medical device, or cosmetic, navigating the complex regulatory requirements can be challenging. Importers and exporters often require legal guidance to comply with labeling, certification, and import regulations. Legal assistance is also vital if you are facing compliance investigations, product recalls, or regulatory disputes. In addition, if you are a consumer suffering from adverse reactions due to a regulated product, a lawyer can help you determine your rights and legal remedies. Lawyers can also help with obtaining necessary licenses, permits, and product registrations, ensuring all regulatory obligations are met.

Local Laws Overview

The primary legal framework for FDA Law in Colombo includes several statutes and regulations. Key among them are:

  • The Food Act, No. 26 of 1980 - Governs food quality, safety, and standards, including labeling requirements.
  • The Cosmetic Devices and Drugs Act, No. 27 of 1980 - Regulates the import, manufacture, sale, and distribution of cosmetics, medical devices, and drugs.
  • The National Medicines Regulatory Authority Act, No. 5 of 2015 - Establishes the NMRA as the main authority for medicine and medical device regulation.
  • Subsidiary regulations - These cover matters such as registration, labelling guidelines, import/export procedures, advertising controls, and food safety management systems.

Companies, importers, and distributors must comply with product registration, labeling standards, licensing, and advertising rules. There are strict penalties for non-compliance, ranging from fines to license suspension or criminal liability. Regular inspections and record-keeping are also mandated to ensure ongoing compliance with these laws.

Frequently Asked Questions

What products are regulated under FDA Law in Colombo?

FDA Law in Colombo covers foods, pharmaceuticals, medical devices, cosmetics, and in some cases, dietary supplements and herbal products.

Who is responsible for enforcing FDA-related regulations in Colombo?

The chief regulators are the National Medicines Regulatory Authority (NMRA) and the Food Control Administration Unit under the Ministry of Health.

Are product registration and licensing mandatory?

Yes, all imported or locally manufactured foods, drugs, and medical devices must be appropriately registered and licensed with the relevant authorities before sale or distribution.

What are the penalties for non-compliance?

Penalties may include fines, suspension or cancellation of licenses, confiscation of goods, and in severe cases, criminal prosecution.

Can a product be recalled in Sri Lanka?

Yes, if a product is found to be unsafe or mislabeled, regulatory authorities can mandate a recall to protect public health.

What labeling requirements apply to food and drug products?

Labels must include accurate information about ingredients, manufacturing and expiry dates, country of origin, batch numbers, storage instructions, and relevant health warnings as per the regulatory guidelines.

Is advertising of drugs and food supplements regulated?

Yes, advertisements must not be misleading and are subject to approval and ongoing monitoring by regulatory bodies prior to and after release.

How can consumers file complaints regarding regulated products?

Consumers can file complaints with the Food Control Administration Unit or the NMRA, depending on the product type, either through their official offices in Colombo or via dedicated hotlines.

Are traditional and Ayurvedic products regulated under FDA Law?

Traditional and Ayurvedic medicines are regulated separately by the Ayurvedic Drugs Corporation and the Department of Ayurveda, with certain overlaps for safety and export purposes.

How long does product registration generally take?

Registration times can vary depending on the product type, completeness of the application, and any necessary laboratory analyses but typically range from a few weeks to several months.

Additional Resources

If you need more detailed information or support, consider reaching out to the following resources and organizations:

  • National Medicines Regulatory Authority (NMRA) - Oversight of medical drugs, devices, and related approvals
  • Food Control Administration Unit, Ministry of Health - Regulator of food safety and standards
  • Sri Lanka Standards Institution (SLSI) - Responsible for standardization and quality assurance
  • Ministry of Health, Nutrition and Indigenous Medicine - Offers guidelines and notifications
  • Consumer Affairs Authority (CAA) - Handles consumer rights, complaints, and enforcement
  • Professional legal associations and law firms in Colombo specializing in regulatory, pharmaceutical, and health law

Next Steps

If you suspect that you need legal assistance in the field of FDA law, begin by gathering all relevant documents, such as licenses, product labels, registration certificates, and any correspondence with regulatory authorities. Clearly outline your concerns or objectives, whether it is a licensing issue, compliance matter, dispute, or consumer complaint. Then consult with a qualified lawyer who specializes in FDA Law and regulatory affairs in Colombo. Many law firms offer initial consultations to evaluate your case and advise on practical options. Depending on the situation, your lawyer can assist you in drafting submissions, representing you before regulatory authorities, or handling dispute resolution. Acting promptly and under qualified legal guidance is essential to ensure compliance and to protect your legal standing in Colombo, Sri Lanka.

Lawzana helps you find the best lawyers and law firms in Colombo 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 Colombo, 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.