:

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19 2003 .

 

N 295-22/121

 

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<1>

 

CERTIFICATE OF A PHARMACEUTICAL PRODUCT <1>

 

,

().

( )

 

This certificate conforms to the
format recommended by the

 

No. of Certificate

 

 

:

Exporting (certifying country):

RUSSIA

 

() :

 

Importing (requesting country):

 

 

:

 

Name and dosage form of the product:

 

 

1.1. <2>
<3>:

 

1.1. Active ingredient(s) <2> and
amount(s) per unit dose <3>:

 

 

,
<4>:

For complete composition including excipients, see attached <4>:

 

1.2. ┌──────┐

? <5> ( ) ├──────┤

1.2. Is this product licensed to be placed on the │YES

market for use in the exporting country? <5> └──────┘

(Key in as appropriate)

 

//YES/NO

 

1.3. ┌──────┐

-? ( )

1.3. Is this product actually on the market in the ├──────┤

exporting country? (Key in as appropriate) │YES

└──────┘

 

// /YES/NO/UNKNOWN

 

1.2. - , 2

2. 1.2. - , 2

2 <6>:

If the answer to 1.2. is YES, continue with section 2A and omit

section 2B. If the answer to 1.2. is NO, omit section 2A and

continue with section 2B <6>:

 

2..1.
<7> :

 

2.A.1. Number of product licence <7> and
date of issue:

 

 

2.A.2.
( )

 

2..2. Product license holder (name and
address):

 

 

2.A.3.
<8>: (
,
<8>)

()

2. .3. Status of product license holder
<8>: (Key in appropriate category as
defined in note <8>)

(a) manufacturer of
the dosage form

 

a/b/c

 

2.A.4. ┌──────┐

? <10> ( )

2..4. Is a summary basis for approval appended? ├──────┤

<10> (Key in as appropriate) │NO

└──────┘

//YES/NO

 

2.A.5.

, ┌──────┐

? <11>

( ) ├──────┤

2..5. Is the attached, officially approved product │YES

information complete and consonant with the licence? └──────┘

<11> (Key in as appropriate)

 

// YES/NO/NOT PROVIDED

 

2.A.6. , ┌──────┐

(

) <12>: ├──────┤

2..6. Applicant for certificate, if different from │NO

license holder (name and address) <12>: └──────┘

 

2.B.1. (
):


2.B.1. Applicant for certificate (name and
address):

NOT
APPLICABLE

 

2.B.2.
(
<8>)


2..2. Status of applicant:
(Key in appropriate category as defined in footnote
<8>)

NOT
APPLICABLE

 

a/b/c

 

2..2.1. (b) ()
,
<9>:


2..2.1. For categories (b) and (c) the name and
address of the manufacturer producing the dosage
form is <9>:

NOT
APPLICABLE

 

2.B.3.
? ( ):


2..3. Why is marketing authorization lacking?
(Key in as appropriate)

NOT
APPLICABLE

 

/ / /

not required/not requested/under consideration/refused

 

┌────────────────────────┬───────────────────────────────────────┐

│2.B.4. <13>:│

├────────────────────────┼───────────────────────────────────────┤

│2.B.4. Remarks <13>: │NO

└────────────────────────┴────────────────────────────────┬──────┤

3. ,

(

), <14>

( ): ├──────┤

3. Does the certifying authority arrange for periodic │YES

inspection of the manufacturing plant in which the

dosage form is produced (Key in as appropriate) └──────┘

 

// <14> /YES/NO/NOT APPLICABLE <14>

"" " ", 4.

If not or not applicable, proceed to question 4.

 

┌───────────────────────────────────────┬────────────────────────┐

│3.1. │2000/2001/2003

│():

├───────────────────────────────────────┼────────────────────────┤

│3.1. Periodicity of routine inspections│2000/2001/2003

│(years):

└───────────────────────────────────────┴─────────────────┬──────┤

3.2.

?

( ) ├──────┤

3.2. Has the manufacture of this type of dosage form been│YES

inspected? (Key in as appropriate)

└──────┘

//YES/NO

┌──────┐

3.3. ,

GMP, │

? <15> (

) ├──────┤

3.3. Do the facilities and operations conform to GMP as │YES

recommended by the World Health Organization? <15> (Key

in as appropriate) └──────┘

 

// <14> YES/NO/NOT APPLICABLE <14>

┌──────┐

4. ,

? <16> ( ) ├──────┤

4. Does the information submitted by the applicant │YES

satisfy the certifying authority on all aspects of the

manufacture of the product <16>: (Key in as appropriate) └──────┘

 

//YES/NO

 

, :

If No, explain:

 

┌──────────────────────────┬─────────────────────────────────────┐

│, :│ ,

│ │

│101479, , ,

│ ., 18/20

├──────────────────────────┼─────────────────────────────────────┤

│Address of certifying │Department of government inspection

│authority: │of drugs and medical equipment of the│

│Ministry of Health of Russian

│Federation

│101479, Vadkovsky per., 18/20

│Moscow, Russia

└──────────────────────────┴─────────────────────────────────────┘

 

/Telephone

 

/Fax

 

...

 

Name of authorized person:

 

:

 

 

Date:

 

 

 

/Signature

/Stamp

 

 

.

. , .

.

 

 

<1> ( - ), , , . , .. .

<2> () .

<3> ( ) .

<4> , .

<5> , , .

<6> 2 2 .

<7> , .

<8> , , :

(a) ;

(b) / , ;

(c) .

<9> , , - . , .

, .

, .

<10> , , .

<11> , , , ().

<12> . .

<13> , :

(a) , , ;

(b) ;

(c) , - ;

(d) ;

(e) .

<14> " " - , , , .

<15> , : , (WHO Technical Report Series, N 823, 1992, 1). (WHO Technical Report Series, N 822, 1992, annex 1).

<16> , (b) () 7 . , . , , , .

 

General instructions

 

Please refer to the guidelines for full instructions on how to complete this form and information on the implementation of the Scheme.

The forms are suitable for generation by computer. They should always be submitted as hard copy, with responses printed in type rather than handwritten.

Additional sheets should be appended, as necessary, to accommodate remarks and explanations.

 

Explanatory notes

 

<1> This certificate, which is in the format recommended by WHO, establishes the status of the pharmaceutical product and of the applicant for the certificate in the exporting country. It is for a single product only since manufacturing arrangements and approved information for different dosage forms and different strengths can vary.

<2> Use, whenever possible, International Nonproprietary Names (INNs) or national nonproprietary names.

<3> The formula (complete composition) of the dosage form should be given on the certificate or be appended.

<4> Details of quantitative composition are preferred but their provision is subject to the agreement of the productlicence holder.

<5> When applicable, append details of any restriction applied to the sale, distribution or administration of the product that is specified in the product licence.

<6> Sections 2A and 2B are mutually exclusive.

<7> Indicate, when applicable, if the license is provisional, or the product has not yet been approved.

<8> Specify whether the person responsible for placing the product on the market:

(a) manufactures the dosage form;

(b) packages and/or labels a dosage form manufactured by an independent company; or

(c) is involved in none of the above.

<9> This information can only be provided with the consent of the product-licence holder or, in the case of nonregistered products, the applicant. Non-completion of this section indicates that the party concerned has not agreed to inclusion of this information.

It should be noted that information concerning the site of production is part of the product licence. If the production site is changed, the licence has to be updated or it is no longer valid.

<10> This refers to the document, prepared by some national regulatory authorities, that summarizes the technical basis on which the product has been licensed.

<11> This refers to product information approved by the competent national regulatory authority, such as Summary Product Characteristics (SPC).

<12> In this circumstance, permission for issuing the certificate is required from the product-licence holder. This permission has to be provided to the authority by the applicant.

<13> Please indicate the reason that the applicant has provided for not requesting registration:

(a) the product has been developed exclusively for the treatment of conditions - particularly tropical diseases - not endemic in the country of export;

(b) the product has been reformulated with a view to improving its stability under tropical conditions;

(c) the product has been reformulated to exclude excipients not approved for use in pharmaceutical products in the country of import;

(d) the product has been reformulated to meet a different maximum dosage limit for an active ingredient;

(e) any other reason, please specify.

<14> Not applicable means the manufacture is taking place in a country other than that issuing the product certificate and inspection is conducted under the aegis of the country of manufacture.

<15> The requirements for good practices in the manufacture and quality control of drugs referred to in the certificate are those included in the thirty-second report of the Expert Committee on Specifications for Pharmaceutical Preparations, WHO Technical Report Series No. 823, 1992, Annex 1. Recommendations specifically applicable to biological products have been formulated by the WHO Expert Committee on Biological Standardization (WHO Technical Report Series, N 822, 1992, Annex 1).

<16> This section is to be completed when the product-licence holder or applicant conforms to status (b) or (c) as described in note 8 above. It is of particular importance when foreign contractors are involved in the manufacture of the product. In these circumstances the applicant should supply the certifying authority with information to identify the contracting parties responsible for each stage of manufacture of the finished dosage form, and the extent and nature of any controls exercised over each of these parties.

 

/Appendix

 

1. N 000704/01-2001

11.10.2001

Registration Certificate P N 000704/01-2001 (11.10.2001).

2. 42 0053157401

Technical documentation CPA 42 0053157401

3. R

Instruction for Medical Use of BRALANGINE

4.

GMP

Certificate of pharmaceutical company with the GMP

requirements

 

 



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