S.L. 458.31 Art. 15Superintendent of Public Health may apply controls. Ref. No. Application medicinal Government This returned and legislation 1. 1.1 Name 1.2 1.3 2. 2.1 2.2 Active 2.3 2.4 List should be (SPC)].

Nothing in these regulations shall preclude the

Superintendent of Public Health from applying any controls and conditions in the case of the procurement and supply of any medicinal product that is covered by the Government Health Services. SCHEDULE I

Regulation 6(1) ................................... Form T01

to the Superintendent of Public Health for the consideration of a product to be covered by the Government Formulary List as per the Health Services (Medicinal Products) Regulations, 2009.

application is to be filled in clearly and completely, otherwise it will be will not be considered. The time lines for the decision specified in the apply once the application is validated and accepted.

Details of Applicant of Marketing Authorisation Holder

Address

Telephone number

Details of Medicinal Product

Product Name

Ingredient

Pharmaceutical form

Strength 2.5 Method and Route of Administration

2.6 Proposed pack size/s to be placed on the Government Formulary

2.7 Indications for which the product is being requested [indications covered by locally approved Summary of Product Characteristics

2.8 Posology / Dosage regimen (as covered by SPC)

2.9 Duration of treatment course (where applicable)

2.10 Pharmacotherapeutic Group: ATC Code ................................ Pharmacotherapeutic Group ...............................