ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

02^nd May, 2022

TMDA AUTHORIZES NOVEL ORAL POLIO VACCINE TYPE 2 (nOPV2) VACCINE FOR EMERGENCY USE DURING OUTBREAK OF POLIOMYELITIS VIRUS TYPE 2.

1. Tanzania Medicines and Medical Devices Authority (TMDA) has authorized for emergence use of Polio Type 2 (nOPV2) vaccine. The authority is issuing this notice pursuant to section 57-(1) of The Tanzania Medicines and Medical Devices Act, Cap 219 of 2019 that empower the Authority to authorize the use of unregistered medicinal products including vaccines for specific purpose.The Ministry of Health has declared nOPV2 vaccine manufactured by PT Bio Farma (Persero), Indonesia to be used during the outbreak of Poliomyelitis Virus Type 2 when is required by Global Polio Eradication Initiative (GPEI) or World Health Organization (WHO).
2. This authorization was based on the safety, quality and efficacy data submitted by applicant through World Health Organization (WHO) Emergency Use Listing (EUL) Procedure. Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unapproved vaccines with the aim of expediting the availability of this product during a declared state of public health emergency.
3. Furthermore, the Authority would like to highlight to the public that, granting of emergency use of this vaccine does not alter the standard regulatory requirements for establishing quality, safety and efficacy required for issuing marketing authorization to the designated products.
4. The summary information of nOPV2 vaccines approved by the authority can be accessed by clicking here

   SUMMARY INFORMATION OF NOVEL ORAL POLIOMYELITIS VACCINE TYPE 2 (nOPV2)

   1.1	Trade name	Novel Oral Poliomyelitis Vaccine Type 2(nOPV2)
   1.2	Generic name	Live attenuated novel poliomyelitis virus type 2
   1.3	Strength of immunogenic substance(s):	Live attenuated novel poliomyelitis virustype 2 ≥ 105.0 CCID50.
   1.4	Dosage form	Clear suspension for oral use.
   1.5	Distribution category	POM
   1.6	Primary Packing materials /Pack size	Type 1 USP grass vial of 5 mL.
   1.7	Secondary Packing materials/Pack size	10 x 5 mL vial in a carton box
   1.8	Route of Administration	Oral
   1.9	Storage condition	nOPV2 stored for up to 36 months when frozen at ≤ - 20˚C, with up to 6 months at 2-8˚C allowed
   1.10	Proposed Shelf life	36 months when frozen at ≤ - 20˚C, with up to 6 months at 2-8˚C allowed
   1.11	Visual Description of finished product as finished product specifications	A clear virus suspension, slightly yellow to light red colour.
   1.12	Applicant	PT Bio Farma (Persero) Jl. Pasteur No. 28 Bandung 40161 Indonesia.
   1.13	Immunogenic substance manufacturer	PT Bio Farma (Persero) Jl. Pasteur No. 28 Bandung 40161 Indonesia
   1.14	Manufacturers	PT Bio Farma (Persero) Jl. Pasteur No. 28 Bandung 40161 Indonesia.
   1.15	Country of origin	Indonesia
   1.16	Therapeutic Indication(s):	Active immunization in all age groups for emergency use in response to outbreaks caused by type 2 poliomyelitis virus when and where it is required by the Global Polio Eradication Initiative (GPEI) or World Health Organization (WHO).

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