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AR 193/2016 PHARMACEUTICAL EQUIPMENT CONTROL REGULATION

(no amdt)

ALBERTA REGULATION 193/2016

Pharmacy and Drug Act

PHARMACEUTICAL EQUIPMENT
CONTROL REGULATION

Definitions

1   In this Regulation,

                               (a)    “Act” means the Pharmacy and Drug Act;

                              (b)    “natural health product” means a natural health product as defined in the Natural Health Products Regulations SOR/2003‑196.

Designated equipment

2   For the purposes of section 18.8 of the Act and this Regulation,

                               (a)    “capsule filling machine” means a mechanical or manual device that

                                        (i)    holds capsules and facilitates their even filling with powders, granular solids, semi-solids, liquids or other substances,


                                      (ii)    may cap or close capsules,

                                     (iii)    is marketed, designed or utilized for drug or natural health product use, and

                                     (iv)    has more than 100 capsule‑holding cavities;

                              (b)    “pharmaceutical mixer” means a mechanical or manual device that

                                        (i)    mixes or blends liquids, semi-solid materials, powders, granular solids or any other substances to produce a homogenous product, and

                                      (ii)    is marketed, designed or utilized for drug or natural health product use,

                                       but does not include a household appliance or device or a device intended for use by a non-pharmaceutical industry or business;

                               (c)    “pill or tablet press”, “tablet machine” or “tablet punch” means a mechanical or manual device that

                                        (i)    compresses, compacts or molds powders, granular solids, semi-solids or other substances into solid tablets, pills or any other form of uniform size and weight, and

                                      (ii)    is marketed, designed or utilized for drug or natural health product use;

                              (d)    “tablet die” means a device used to cut, shape or impress a design into a tablet or pill and is marketed, designed or utilized for drug or natural health product use.

Exemption

3   The following are exempt from section 18.81(1) of the Act:

                               (a)    a person authorized to compound or manufacture natural health products under an Act or regulation of Alberta or Canada;

                              (b)    a person or museum who collects, sells or restores historical or reproduction designated equipment that is considered to be a historic object as defined under the Historical Resources Act.

Coming into force

4   This Regulation comes into force on the coming into force of section 2 of the Pharmacy and Drug (Pharmaceutical Equipment Control) Amendment Act, 2016.