Marginal note:Amount payable

3. The fee that is payable for an establishment licence is the sum of the fees referred to in sections 4 to 10, as applicable.

Marginal note:Licence authorizing fabrication

• 4. (1) The fee payable for each site at which one or more activities is authorized by the establishment licence including the fabrication of drugs is the basic fee, set out in column 2 of item 1 of Schedule 1, together with each of the following fees that are applicable:

  • (a) if the licence is in respect of more than one category of drugs, the fee set out in column 2 of item 2 of Schedule 1, for each additional category;

  • (b) if the licence is in respect of more than one dosage form class, the applicable fee set out in column 2 of item 3 of Schedule 1; and

  • (c) if the licence is in respect of sterile dosage forms, the fee set out in column 2 of item 4 of Schedule 1.

• Marginal note:Importing

  (2) Despite section 6, if importing is authorized by the establishment licence at a site referred to in subsection (1), the fee referred to in paragraph 6(b) is also payable.

Marginal note:Licence authorizing packaging/labelling

• 5. (1) The fee that is payable for each site at which one or more activities is authorized by the establishment licence, including packaging/labelling drugs but not including fabricating drugs, is the basic fee, set out in column 2 of item 1 of Schedule 2, together with each of the following fees that are applicable:

  • (a) if the licence is in respect of more than one category of drugs, the fee set out in column 2 of item 2 of Schedule 2, for each additional category; and

  • (b) if the licence is in respect of more than one dosage form class, the applicable fee set out in column 2 of item 3 of Schedule 2.

• Marginal note:Importing

  (2) Despite section 6, if importing is authorized by the establishment licence at a site referred to in subsection (1), the fee referred to in paragraph 6(b) is also payable.

Marginal note:Licence authorizing importation

6. The fee that is payable for one or more activities authorized by the establishment licence, including importing drugs but not including fabricating or packaging/labelling drugs, is

• (a) for each site where those activities are so authorized, the basic fee, set out in column 2 of item 1 of Schedule 3, together with each of the following fees that are applicable:

  • (i) if the licence is in respect of more than one category of drugs, the fee set out in column 2 of item 2 of Schedule 3, for each additional category, and

  • (ii) if the licence is in respect of more than one dosage form class, the applicable fee set out in column 2 of item 3 of Schedule 3; and

• (b) for each fabricator outside Canada of drugs that are imported, except where a certificate from a Canadian inspector indicating that the fabricator’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4 of Part C of the Food and Drug Regulations is provided by the importer, the sum of the following fees that are applicable:

  • (i) the fee set out in column 2 of item 4 of Schedule 3, and

  • (ii) if the licence is in respect of more than one dosage form class, for each additional dosage form class, the fee set out in column 2 of item 5 of Schedule 3.