Commercial Importers of Pharmaceutical Products Registration Application Form – 2018 Page 1 of 5 25 Church Street, Hamilton, HM 12, Bermuda

P.O. Box HM 1195, Hamilton HM EX, Bermuda

Phone: (441) 278-4961 Fax: (441) 292-2629 E-mail: OfficeofCMO@gov.bm

Guidance for Recognition as a Commercial Importer of Pharmaceutical Products

This form is required to be completed to apply for recognition by the Ministry of Health as a Commercial

Importer of Pharmaceutical Products. The below guidelines and subsequent checklist must first be read,

understood and agreed to ahead of completion and submission of this form.

Guidelines for Recognized Commercial Importer of Pharmaceuticals

1. All intended Commercial Importers of Pharmaceutical Products are required to become recognized by

the Ministry of Health. Applications should be submitted to the Ministry of Health, Office of the Chief

Medical Officer (Office of the CMO), OfficeofCMO@gov.bm or Continental Building - 25 Church

Street, Hamilton HM 12, Bermuda.

2. The application process requires submission of an Individual Criminal Background Vetting and

reports of inspection of the premises by both the Pharmacy Inspector and the Bermuda Police

Service to ensure security and appropriateness of the intended storage site.

- Bermuda Police Services – Individual Criminal Background Vetting: contact Hamilton Police Headquarters.

- Bermuda Police Services – Security Inspection of Premise: contact Act. Inspector Shakeisha Minors sminors@bps.bm to arrange.

- Pharmacy Inspector – contact Pharmacist@gov.bm to arrange.

3. Any drug listed in Schedule 3 (prescription medication) that is intended for import into Bermuda

must adhere to Section 25(1) of the Pharmacy and Poisons Act 1979. This requires the medicine to

be eligible for sale within the United States of America, Canada or the European Union in

accordance with the regulatory standards of one of the aforementioned jurisdictions.

4. If the drug to be imported is also classified as a Controlled Drug, under Schedule 2 of the Misuse of

Drugs Act 1972, the importer must also obtain a controlled drug license from the Office of the

CMO prior to importation. This is a separate process for each controlled drug importation request.

5. Importers can sell products only to registered pharmacies, pharmacists or medical practitioners

according to Sections 29 and 45 of the Pharmacy and Poisons Act 1979.

Commercial Importers of Pharmaceutical Products Registration Application Form – 2018 Page 2 of 5 25 Church Street, Hamilton, HM 12, Bermuda

P.O. Box HM 1195, Hamilton HM EX, Bermuda

Phone: (441) 278-4900 Fax: (441) 292-2629 E-mail: OfficeofCMO@gov.bm

6. Importers will be monitored for compliance to existing restrictions on importation and distribution

locally by the Pharmacy Inspector, as outlined in the Pharmacy and Poisons Act 1979 and Misuse of

Drugs Act 1972.

7. Importers must maintain records of purchases and sales of all imported Schedule 3 drugs and

controlled drugs. See Schedule 3 of the Misuse of Drugs Regulations 1973 for the format of the

register for controlled drugs.

8. Commercial importers of prescription drugs (Schedule 3, Pharmacy and Poisons Act and Misuse of

Drugs Legislation) must employ a Pharmacist, registered as their designated manager, who must

be present at their place of business during working hours. Importers of Schedule 4 drugs do not

have to meet this requirement.

N.B. The above guidelines are in addition to the obligations under the Revenue Act 1898 for the commercial importation of products to Bermuda.

Standards for Storage of Pharmaceutical Products

STORAGE STANDARDS

A. Storage facilities of pharmaceutical products must have a room or rooms dedicated for storage of pharmaceutical products only, and shall be locked. The storage area of the storerooms should not be less than 100 square feet or should be proportionate to the scale of relevant business.

B. Precautions must be taken to prevent unauthorized persons from entering storeroom.

C. Storeroom should be of sufficient capacity to allow the orderly storage of the various categories of pharmaceutical products, for example: products in quarantine, released, rejected, returned or recalled products.

D. Storeroom should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature and humidity limits. Pharmaceutical products should be stored off the floor and suitably spaced to permit cleaning and inspection. Pallets should be kept in a good state of cleanliness and repair.

E. Storeroom should be clean, and free from accumulated waste and vermin. A written sanitation programme should be available indicating the frequency of cleaning and the methods to be used to clean the premises and storeroom. There should also be a written programme for pest control. The pest-control agents used should be safe, and there should be no risk of contamination of pharmaceutical products. There should be appropriate procedures for the clean-up of any spillage to ensure complete removal of any risk of contamination.

F. Receiving and dispatch area should protect products from the weather. Receiving area should be designed and equipped to allow incoming containers of pharmaceutical products to be cleaned, if necessary, before storage.

G. Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorized personnel. Any system replacing physical quarantine should provide equivalent security.

Commercial Importers of Pharmaceutical Products Registration Application Form – 2018 Page 3 of 5 25 Church Street, Hamilton, HM 12, Bermuda

P.O. Box HM 1195, Hamilton HM EX, Bermuda

Phone: (441) 278-4900 Fax: (441) 292-2629 E-mail: OfficeofCMO@gov.bm

H. Physical and/or other equivalent (e.g. electronic) segregation should be provided for the storage of

rejected, expired, recalled, or returned products. The products and area should be appropriately identified.

I. Dangerous drugs, psychotropic substances, narcotics and cytotoxic drugs should be stored in dedicated areas that are subject to appropriate additional safety and security measures.

J. Pharmaceutical products should be handled and stored in such a manner as to prevent contamination, mix-ups and cross-contamination.

K. A system should be in place to ensure that pharmaceutical products due to expire first are sold and/or distributed first. Exceptions may be permitted as appropriate, provided that adequate controls are in place to prevent the distribution of expired products.

L. Rejected pharmaceutical products should be identified and controlled under a quarantine system designed to prevent their use until a final decision is taken on their fate.

M. Broken or damaged items should be stored separately from usable stock and disposed properly.

N. Storeroom should be provided with adequate lighting to enable all operations to be carried out accurately and safely.

O. Storage conditions for pharmaceutical products should be in compliance with the instructions on the label, which are based on the results of stability testing.

P. Recorded refrigeration temperature monitoring data should be available for review. The equipment used for monitoring should be checked at suitable predetermined intervals and the results of such checks should be recorded and retained. All monitoring records should be kept for at least the shelf-life of the stored pharmaceutical product plus one year. Temperature should be uniform across a climate-controlled storage facility.

Q. Equipment used for monitoring of storage conditions should be calibrated and maintained at defined intervals. Relevant records should be kept and available for inspection by the Ministry of Health.

R. Questionable storage conditions should be reported to Ministry of Health, Pharmacy Inspector for advice (pharmacist@gov.bm).

S. Periodic stock reconciliation should be performed by comparing the actual and recorded stocks.

T. All significant stock discrepancies should be investigated to check that there have been no inadvertent mix-ups, incorrect issue and/or misappropriation of pharmaceutical products.

U. Any breakage of security, or any unexplainable stock discrepancy should be reported to Ministry of Health, Pharmacy Inspector (pharmacist@gov.bm).

Should you require additional information or need to make further requests regarding drug importation contact the Pharmacy Inspector at pharmacist@gov.bm, or the Registrations Manager at OfficeofCMO@gov.bm.

Commercial Importers of Pharmaceutical Products Registration Application Form – 2018 Page 4 of 5 25 Church Street, Hamilton, HM 12, Bermuda

P.O. Box HM 1195, Hamilton HM EX, Bermuda

Phone: (441) 278-4900 Fax: (441) 292-2629 E-mail: OfficeofCMO@gov.bm

Application for Recognition as a Commercial Importer of Pharmaceutical Products

Instructions for Completing this Form

This form is required to be completed to apply for recognition as a Commercial Importer of Pharmaceutical Products. Before submitting this application form please ensure you read, understand and agree to the guidelines and storage requirements. Complete all sections of the application. Please print legibly or type in blue or black ink.

Provide information on additional paper if the space on the form is inadequate for a complete response. Applications are to be submitted to: The Office of the Chief Medical Officer, 25 Church Street, Hamilton HM 12, Bermuda or OfficeofCMO@gov.bm. We recommend you keep a copy for your files.

SECTION A: OWNERSHIP AND BUSINESS DETAILS

Name of Business:

Business Physical Address:

Street Number Street Name

Address Line 2

Address Line 3

Telephone: Fax Number:

Email Address:

Website:

Intended Hours of Operation:

Mailing Address (If different):

Street or P.O. Box Number

Address Line 2

Address Line 3

Business Owner’s Name:

First Name Middle Name(s) Last Name

2nd Business Owner’s Name:

First Name Middle Name(s) Last Name

Commercial Importers of Pharmaceutical Products Registration Application Form – 2018 Page 5 of 5 25 Church Street, Hamilton, HM 12, Bermuda

P.O. Box HM 1195, Hamilton HM EX, Bermuda

Phone: (441) 278-4900 Fax: (441) 292-2629 E-mail: OfficeofCMO@gov.bm

SECTION B: IMPORTS SUPERVISOR DETAILS (if individual is different from Business Owner)

Telephone: Fax Number:

Email Address:

Mailing Address (If different):

Street or P.O. Box Number

Address Line 2

Address Line 3

SECTION C: REGISTERED PHARMACIST / DESIGNATED MANAGER DETAILS (where applicable for importers

of Schedule III Pharmacy and Poisons Act and Misuse of Drugs Act pharmaceutical products)

Telephone: Fax Number:

Email Address:

Mailing Address (If different):

Street or P.O. Box Number

Address Line 2

Address Line 3

SECTION D: ATTESTATION STATEMENT

The undersigned hereby makes application for registration as a Recognized Commercial Importer of Pharmaceutical Products in Bermuda. I, the undersigned, verify that the information contained in this application and any attachments thereto are true, accurate and correct to the best of my knowledge. I have read, understand and agree to adhere to the guidelines and requirements of a Commercial Importer. I understand that false statements may result in the revocation of my company’s recognition as a Commercial Importer.

Print Applicant’s Name

Signature of Applicant Date Updated: Feb 2018

Name of Person Supervising Imports:

First Name Middle Name(s) Last Name

Relevant Qualifications of Importation Supervisor:

Name of Person Registered Pharmacist /

Designated Manager:

First Name Middle Name(s) Last Name

Bermuda Pharmacy Council Registration Number: