PharmaWatch Jamaica – Frequently Asked Questions (FAQ)

Are there any regulations in your country for pharmacovigilance? Can you please provide these regulations?

The Food & Drugs Act and Regulations 1964 & 1975 respectively do require prompt reporting of an ADR to the Minister of Health once a drug has been approved for use/sale in Jamaica.

“70. Where any person receives any report of any unexpected side effects, injury, toxicity or sensitivity reaction associated with clinical uses, studies, investigation and tests respecting any new drug, he shall immediately inform the Minister thereof, furnishing him with the full information available.” (Food & Drugs Act, 1975)

We have therefore established policies and working guidelines based on the law.

 

Which is the acceptable language for reporting?

The official language of the country is English. Whilst documents may be submitted to the Ministry in various languages English must be the principal language used. If another language is used then an authenticated English translation must accompany the document.

 

Is it mandatory to have legal representation in the Country to report? Can it be delegated to a third party by the Pharmaceutical Company?

Whilst we request that International companies have a local representative that liaises with the Ministry, adverse event reports may be directly sent and do not specifically require a presence in the country.

 

Can the report be made through email? Fax? CD?

The Law requires that the Minister of Health be immediately informed, providing the “full information available”. Since it does not specify a format for reporting we have facilitated the industry through acceptance of faxed or emailed reports. Fax or email is best for single spontaneous reports. We do however expect that such information will be provided in a written format that is acceptable for regulatory purposes. Our local Pharmwatch form can be found on the Ministry’s website www.moh.gov.jm under “Standards & Regulation”.

 

What is the name and contact information of the authority to report to?

Please send your email to:

Ms. Angelika Steiner, Contact Person – Pharmwatch Jamaica:
SteinerA@moh.gov.jm

Copy your email to Mrs. Valerie Germain – Acting Director of Standards & Regulation:
GermainV@moh.gov.jm
FAX: (876) 630-3630
Tel: (876) 633-7150 or (876) 633-7148

Address: Mrs. Valerie Germain
Acting Director of Standards & Regulation
Standards & Regulation Division
Ministry of Health
Masonic Building, 45-47 Barbados Avenue
Kingston 5
Jamaica W.I.

 

Please indicate if the following events should be reported and the timelines for reporting. Is there a standard format or template to notify?

a. Local non serious adverse events?

Report within 72 hours up to five (5) days of your receiving information regarding a local non-serious adverse event (AE). No template or standard format.

b. Local serious adverse events?

Serious adverse events (expected and unexpected) occurring locally must be reported within 24-48 hours of your receiving information regarding a serious AE. No template or standard format.

c. International serious events (expected and unexpected)?

Serious adverse events (expected and unexpected) occurring overseas/internationally must be reported within 24-48 hours of your receiving information regarding a serious AE. No template or standard format.

IMPORTANT: Serious adverse events (expected and unexpected) are reported irrespective of the circumstance so that serious adverse events (expected and unexpected) in a clinical trial that involves Jamaica or a drug registered in Jamaica would have to be promptly reported, likewise a serious event occurring post market. For products not yet on the market these would have to be reported at the time of drug registration.

d. International adverse events? (clinical trials) Indicate timelines please provide standard format or template to notify if it exists.

Should be reported every six (6) months (biannually), no template or standard format. We prefer to receive this data on CD. Do not send masses of emails with extensive attachments.

e. International adverse events? (registered products)

Should be reported every six (6) months (biannually), no template or standard format. We prefer to receive this data on CD. Do not send masses of emails with extensive attachments.

 

Is it required to present a particular report to request new drug registration or renewal?

Please email to VirgoK@moh.gov.jm for further information.

 

Should Periodic Safety Update Reports (PSURs) be reported? Indicate timelines.

PSURs should be reported every six (6) months (biannually) on a CD.