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Application Procedures & Application Forms

Contained Use

When undertaking genetic modification procedures for the first time, premises must be registered with MEPA specifying their first activity by submitting an application for first time use. Activities of Class 1 and above need to notify MEPA of each new activity through an application for individual contained use activities. However, those premises that undertake Class 1 need only notify the information listed in Schedule V Part B, but are required to keep record of each risk assessments, which will be made available to MEPA on request.

The following table gives a summary of the different notification processes required for different classes of micro-organisms.

CLASS 1
Negligible Risk

CLASS 2
Low Risk

CLASSES 3 & 4
Moderate & High Risk

PREMISES ALREADY NOTIFIED


PREMISES
NOT
NOTIFIED

PREMISES ALREADY NOTIFIED


PREMISES
NOT
NOTIFIED

PREMISES ALREADY NOTIFIED


PREMISES
NOT
NOTIFIED

Class 1

submit notification with registration fee and proceed

always keep record of each assessment to be available on request

Class 1

submit First Time use notification with registration fee

once approved, proceed with experiment

always keep record of each assessment to be available on request

Class 2

submit individual contained use notification with registration fee and proceed

or

OPTIONAL

request decision on a formal authorisation by the competent authority (within 45 days)

Class 2

submit First Time use notification with registration fee

then proceed 45 days after submission or earlier with the agreement of the competent authority

Class 3 & 4

submit individual contained use notification with registration fee

then proceed after written decision at least 45 days after submission

Class 3 & 4

submit First Time use notification with registration fee

then proceed after written decision at least 90 days after submission



Application form for Notification for First Time Use

Application form for Individual Contained Use Activities

The application forms can be filled in and submitted to: GMOs, Ecosystems Management Unit, Malta Environment and Planning Authority, St. Francis Ravelin, Floriana, FRN 1230.

 

 

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