IMPLEMENTATION LEVEL

National

AFFECTED FLOW

Inflow

ANNOUNCED AS TEMPORARY

No

NON-TRADE-RELATED RATIONALE

No

ELIGIBLE FIRMS

all

JUMBO

No

TARIFF PEAK

No
← back to the state act
Inception date: 28 Feb 2017 | Removal date: open ended
Still in force

Public procurement localisation

Article 6(2) of the regulation also stipulates that the provision of pharmaceutical goods and medical equipment by the government or by private entities for the needs of the community shall prioritise those goods that use local raw materials.

There are no clear rules on what percentage the local content requirements shall be set. However, there are some indications in the appendix of the regulation: for instance, during the research and development stage, the content shall be at least 25% (p.82). In the production process, the content shall be at least 35%.

Furthermore, the regulation mentions reducing the current import market share from 94% to 45% by 2035 (p.79).

In general, the pharmaceutical industry shall be developed using three strategies:

  1. "Reverse Engineering (Observe, Imitate, Modify)
  2. Joint Venture (transferring technology)
  3. Pioneer Research" (own translation; p.79 of the regulation)

The regulation came into force on 28 February 2017.

AFFECTED COUNTRIES

MAP
TABLE
EXPORT

AFFECTED SECTORS AND PRODUCTS

352 Pharmaceutical products
3001 Glands and other organs for organotherapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organotherapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or
300190 Other
3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micr
300210 Antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes
300220 Vaccines for human medicine
300230 Vaccines for veterinary medicine
300290 Other
3003 Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale.
300310 Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives
300320 Containing other antibiotics
300340 Containing alkaloids or derivatives thereof but not containing hormones or other products of heading 29.37 or antibiotics
300390 Other
3004 Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packin
300410 Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives
300420 Containing other antibiotics
300431 Containing insulin
300432 Containing corticosteroid hormones, their derivatives or structural analogues
300439 Other
300440 Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 29.37 or antibiotics
300450 Other medicaments containing vitamins or other products of heading 29.36
300490 Other
3005 Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes.
300590 Other
3006 Pharmaceutical goods specified in Note 4 to this Chapter.
300610 Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue adhesives for surgical wound closure; sterile laminaria and sterile laminaria tents; sterile absorbable surgical or dent
300620 Bloodgrouping reagents
300630 Opacifying preparations for Xray examinations; diagnostic reagents designed to be administered to the patient
300640 Dental cements and other dental fillings; bone reconstruction cements
481 Medical & surgical equipment & orthopaedic appliances
9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electromedical apparatus and sighttesting instruments.
901811 Electrocardiographs
901812 Ultrasonic scanning apparatus
901813 Magnetic resonance imaging apparatus
901819 Other
901831 Syringes, with or without needles
901832 Tubular metal needles and needles for sutures
901839 Other
901850 Other ophthalmic instruments and appliances
901890 Other instruments and appliances
9022 Apparatus based on the use of Xrays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus, Xray tubes and other Xray generators, high tension generators,
902212 Computed tomography apparatus
902214 Other, for medical, surgical or veterinary uses
902219 For other uses
902229 For other uses
902290 Other, including parts and accessories

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