Consultation Workshop · Tuesday 20 October 2026

Draft Barbados Medical Products Regulations and Clinical Trial Regulations

The Barbados Medical Products Authority and the Ministry of Health and Wellness, with kind sponsorship from PAHO/WHO and in collaboration with the European Union, are completing the Regulations that put the Barbados Medical Products Act, 2026 into practice. This guide explains what the drafts require, who they affect and how to respond.

See what changes for you Ask BMPA AI Read the Act explained Send Comment to BMPA Email BMPRA@barbados.gov.bb

When: Tuesday 20 October 2026, 09:00–16:00Lunch provided
Where: PAHO/WHO Office for Barbados and the Eastern Caribbean CountriesConference Room, Bridgetown
Organised by: Barbados Medical Products Authority and the Ministry of Health and WellnessWith kind sponsorship from PAHO/WHO and in collaboration with the European Union
Written comments: BMPRA@barbados.gov.bbRequested by noon on Friday 16 October; the Next Steps session sets out the process from here

Organised byBarbados Medical Products AuthorityMinistry of Health and Wellness

With kind sponsorship fromPan American Health Organization (PAHO/WHO)

In collaboration withEuropean Union

DraftThis website and the process it describes are drafts

They have been prepared for demonstrative purposes and to support stakeholder engagement. This is not an official publication of the Barbados Medical Products Authority or the Government of Barbados, and nothing here is legal advice. The Barbados Medical Products Act, 2026 and the final Regulations govern.

Featured · Consultation open

Comment on the BMPA Act and the draft Regulations

Read each section of the Act in plain language, open the exact page of the Act or the drafts, and send your comments to the BMPA consultation inbox.

BMPRA@barbados.gov.bb

Send Comment to BMPA

Programme

Workshop agenda

Times are Barbados time. On the day, the current session is highlighted.

Focus questions for the 13:30 session

The organisers want feedback on five areas

Where things stand

Barbados Medical Products Act, 2026 (Act 2026-12) passed in June and is awaiting proclamation.Act s.80
After the workshop, the drafts go to the Minister of Health and Wellness and then to Cabinet.Invitation
Both sets of Regulations come into force six months after publication.MPR 177 · CTR 57
The supporting Guides and Schedules (fees, reliance list, reporting facilities) are still being written.Cover letter

What the BMPA will regulate

Regulatory functions under the Act

The main areas of work the Act gives the Authority, and where each is covered on this site.

Medicines

Registration and marketing authorisation, reliance on trusted regulators, parallel import, classification and supply.

Act Part VI · MPR 16–31

Medical devices and IVDs

Devices and in-vitro diagnostics fall within the Act's definition of medical products and need authorisation before sale.

Act s.2 · Act Part VI

Vaccines and biologics

Vaccines, biologics and blood products are medical products under the Act. Vaccine lot release is one of the functions WHO benchmarks.

WHO Global Benchmarking Tool

Clinical trials

Authorisation, ethics approval, safety reporting and oversight of trials of medical products in Barbados.

Act s.55 · Clinical Trial Regulations

Inspections and licensing

Pharmacy premises certificates, establishment licences for manufacture, import, wholesale and export, and inspection.

Act Parts III, V and X · MPR 80–113

Market surveillance

Pharmacovigilance, recalls, substandard and falsified products, and control of advertising.

Act Part VII · MPR 56–79, 114–138

Vision (draft)

To be a leading, trusted and internationally recognised regulatory authority.

Mission (draft)

To protect and promote public health through science-based regulation.

Section 2 of 10

The Barbados Medical Products Act, 2026

Every section of the Act explained in plain language, with the full statutory text, a link that opens the exact page of the Act, and every place the section is picked up in the draft Regulations and on this site.

Draft guideHow to read this page

Act 2026-12 was passed in June 2026 and awaits proclamation (s.80). The explanations are a plain-language draft prepared for the consultation; the text of the Act governs. Open the full Act · Download the PDF

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Section 3 of 10

What the drafts require

Duties by type of organisation, a part-by-part digest of both drafts, the deadlines they set and the drafting points worth raising. Every reference opens the page in the draft.

Read the draft Medical Products Regulations Read the draft Clinical Trial Regulations

What changes for you

Pick your organisation to see the duties that apply

Drawn from the Act and the two draft Regulations. References read “Act s.” for the Act, “MPR” for the draft Medical Products Regulations and “CTR” for the draft Clinical Trial Regulations.

The two drafts, part by part

What the Regulations say

A plain-language digest of each Part of the draft Medical Products Regulations (177 regulations, 16 Schedules and Guides) and the draft Clinical Trial Regulations (57 regulations). Search to find a topic.

Every regulation, in full

Read any regulation and open it in the document

All 177 draft Medical Products Regulations and 57 draft Clinical Trial Regulations. Open one to see it in brief, its full text, the Act section it puts into practice, any points for comment, and a link that opens the draft at that page.

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Time limits

The deadlines in the Act and the drafts

Pick an event and a date to work out when something is due. The drafts count in days without saying whether calendar or working days; the calculator uses calendar days.

Event Starting date

Points for comment

Drafting issues and gaps worth raising

The organisers asked for provisions that are unclear, impracticable or likely to have unintended effects. These are points found in a close reading of the drafts. Choose one to start a comment.

Section 4 of 10

Read the Act and the draft Regulations

The full documents for the consultation, page by page. Every reference on this site, such as Act s.45, MPR 118 or CTR 43, opens the right page here.

Barbados Medical Products Act, 2026 Page of – Open original ↗ Download

Choose a document.

DraftThe Regulations and lists are discussion drafts circulated for comment and will change. The Act is reproduced for reference; the official gazetted text governs. Comments to BMPRA@barbados.gov.bb.

Section 5 of 10

Medicine lists, registration and processes

Check where a medicine sits on the draft lists, find the right registration route, and follow the main BMPA processes step by step.

Draft medicine classification lists

Prescription only, pharmacy only or general sale?

Search the draft lists circulated for comment. Strength and pack size decide the category. Purple notes mark wording you may want to raise.

The three tiers

POM

Prescription Only Medicine. Supplied by a pharmacist on a practitioner's prescription (Act s.34). Any new class or molecular structure is POM until reclassified.

Pharmacy Only. No prescription, but sold by the pharmacist from an area the public cannot reach, with advice or referral as needed.

GSM

General Sale Medicine. Sold outside a pharmacy only when the product, ingredient, strength, form and pack size are designated by the Authority. General sale products need a patient information leaflet (MPR 48).

Chronic-disease bridge supply: up to 10 days for diabetes, hypertension, asthma, epilepsy or other chronic disease, where a prescription not older than six months is lodged.

Full draft lists

The complete Prescription Only, Pharmacy Only and General Sale lists

Every entry from the draft lists circulated for comment, as written. Search across all three lists, or browse one list at a time. Open the original lists.

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Marketing authorisation

Which registration route fits your product?

No medical product may be imported, sold or advertised without registration and marketing authorisation (Act s.43). Answer up to four questions.

Penalties

Breach	Source	Amount
Manufacturing without a licence (administrative penalty)	Act s.31	$15,000
Most other administrative breaches: uncertified pharmacy, unregistered product, unlicensed import, storage or export, unapproved advertising	Act s.21–55	$5,000
Offences under the Regulations, or obstructing or misleading an inspector	MPR 171 · CTR 50 · Act s.70–73	up to $50,000 and/or 2 years

Under the drafts, each day an offence continues is a separate offence, due diligence is a defence, and directors who take part are liable (MPR 172–175; CTR 51–54). Administrative penalties are payable within 30 days or appealed (Act s.67–68).

Step by step

How the main processes work

Forms and fees will be set in the Guides and Fee Schedule, which are still being written.

Section 6 of 10

WHO benchmarking and where Barbados fits

WHO maturity levels, the functions WHO assesses, and how the BMPA can rely on other regulators.

Where Barbados fits

WHO maturity levels, PAHO, and the regulators the BMPA can rely on

WHO measures regulators with its Global Benchmarking Tool (GBT), on a scale of four maturity levels. PAHO supports Barbados through this process. The Act lets the BMPA rely on trusted regulators' decisions, taking WHO's list of trusted authorities into account (Act s.57).

WHO Global Benchmarking Tools ↗ PAHO: the GBT in the Americas ↗ WHO list of ML3 and ML4 regulators ↗ WHO Listed Authorities ↗

What maturity levels are used for

A standard global measure of how a regulator performs.
Identifying gaps and strengths in a national regulatory authority.
Guiding the country's Institutional Development Plan.
Supporting WHO programmes such as WHO Listed Authority designation, which builds on sustained high performance.

WHO's GBT and manuals are available in several official WHO languages: who.int/tools/global-benchmarking-tools

The nine functions WHO benchmarks, and where the drafts cover them

How reliance fits together

Other regulators

Status as published by WHO (WHO Listed Authorities, August 2025; list of NRAs at ML3 and ML4, August 2026) and PAHO (regional reference authorities, June 2026). No authority in Latin America or the Caribbean appears on WHO's ML3/ML4 list as at August 2026.

Section 7 of 10

Frequently asked questions

General questions about the consultation and the questions stakeholders have raised on the drafts, with the answers so far.

FAQ

Frequently asked questions

General questions about the consultation, followed by the questions suppliers, distributors and reviewers have sent in on the drafts. Each answer shows where it comes from. Many are still open and will be settled at the workshop or in the Guides. Can't find yours? Ask BMPA AI below.

About the Certificate of Pharmaceutical Product (CPP)

A CPP is issued by the regulator of the exporting country under the WHO Certification Scheme. It confirms the product is authorised there and made under GMP. The draft relies on it for the accelerated route (MPR 19, 22).

The certifying country doesn't have to be where the finished product is made or exported from, provided GMP is declared.
Recipient regulators shouldn't normally require CPPs from more than one authority.
A separate GMP certificate isn't needed when the CPP includes a GMP declaration; inspection is a risk-based decision.
Legalisation of a CPP isn't part of the Scheme and adds no assurance.
Alternatives include approval letters from established regulators, EMA opinions, European Commission decisions and regulator website listings.

Source: WHO Certification Scheme Q&A, WHO Drug Information Vol. 30 No. 3 (2016).

Answer labels

Preliminary response from the drafting team; subject to change.

From the draft what the draft text says.

WHO guidance from the WHO Certification Scheme Q&A; Consultation information from the invitation, cover letter and agenda.

Open not settled; raise it at the workshop or in a comment.

Section 8 of 10

Ask BMPA AI

Ask about the Act, the draft Regulations, the medicine lists or the workshop. Answers come with references.

Ask BMPA AI

Ask BMPA AI about the Act, the drafts or the lists

BMPA AI searches the Act, both draft Regulations, the full medicine lists and the workshop details, and answers with references that open the right section or page. Where the documents are silent it can add general guidance from trusted authorities such as WHO, PAHO and CARPHA, clearly labelled as such.

It is a guide to draft material, not legal advice. If it can't answer, email BMPRA@barbados.gov.bb

Ask BMPA AIDocument search

Section 9 of 10

Comment on the BMPA Act and the draft Regulations

Prepare a comment on the Act, the draft Regulations or the medicine lists, and email it to BMPRA@barbados.gov.bb.

Documents and comments

What was circulated, and how to send a comment

Draft for discussion

Barbados Model Medical Products Regulations

Marketing authorisation, establishment licensing, vigilance, quality, market surveillance, promotion, import and export, inspection and laboratory testing.

Read the draft

Draft for discussion

Barbados Model Clinical Trial Regulations

Authorisation, safety, oversight and conduct of clinical trials of medical products.

Read the draft

For comment

POM, Pharmacy Only and General Sale lists

Proposed classification by category, strength and pack size.

Browse the full lists

In force on proclamation

Barbados Medical Products Act, 2026

The Act the Regulations put into practice: 14 Parts, 80 sections.

Read the Act explained

Ready to send

Send Comment to BMPA

Send to BMPRA@barbados.gov.bb

If the email button does nothing on your device, copy the text into a new email to the address above.

Section 10 of 10

Contact the consultation team

Email the consultation inbox at BMPRA@barbados.gov.bb, or use the form to prepare your message.

Contact

Reach the consultation team

Comments, nominations and follow-up

Email the BMPA consultation inbox:

BMPRA@barbados.gov.bb

Lindsay Bynoe Barbados Medical Products Authority · Assistant Director – Drug Regulations (Ag), Barbados Drug Service 6th Floor, Warrens Towers II, Warrens, St Michael

Office+1 246 535 4335

Emaillindsay.bynoe@drugservice.gov.bb

Dr Maryam Karga Hinds Chief Executive Officer (Designate), Barbados Medical Products Authority

Emailmaryam.hinds@barbados.gov.bb

Send us a message

Name Email

Organisation Sector

Country Topic

Phone number Preferred follow-up

Message

Draft Barbados Medical Products Regulations and Clinical Trial Regulations

Comment on the BMPA Act and the draft Regulations

Workshop agenda

The organisers want feedback on five areas

Regulatory functions under the Act

Medicines

Medical devices and IVDs

Vaccines and biologics

Clinical trials

Inspections and licensing

Market surveillance

To be a leading, trusted and internationally recognised regulatory authority.

To protect and promote public health through science-based regulation.

Pick your organisation to see the duties that apply

What the Regulations say

Read any regulation and open it in the document

The deadlines in the Act and the drafts

Drafting issues and gaps worth raising

Prescription only, pharmacy only or general sale?

The complete Prescription Only, Pharmacy Only and General Sale lists

Which registration route fits your product?

How the main processes work

WHO maturity levels, PAHO, and the regulators the BMPA can rely on

How reliance fits together

Other regulators

Frequently asked questions

Ask BMPA AI about the Act, the drafts or the lists

What was circulated, and how to send a comment

Barbados Model Medical Products Regulations

Barbados Model Clinical Trial Regulations

POM, Pharmacy Only and General Sale lists

Barbados Medical Products Act, 2026

Comment builder

Questions raised, and the organisers' answers

Reach the consultation team

Send us a message

Contact inbox