(The below “sim­ple docu­ment” is found from a link here on Erfa’s web­site, or you can copy and paste the below to your Word. )

In addi­tion to the presc­rip­tion of the phy­si­cian men­tio­ning THYROID and the dosage reques­ted (30 mg or 60 mg or 125 mg), we will also need this docu­ment to be filled in and given to the phar­ma­cist for the deli­very of THYROID

DECLARATION of THE PHYSICIAN

This dec­la­ra­tion is inten­ded to the phar­ma­cist for the deli­very of a pro­duct, for which no “Mar­ket Autho­ri­za­tion” exists at the moment.

Name and Fore­name of the presc­ri­bing physician: ………….………………………….………

Address:          Street and number……………………………………………………………….

City and postcode……………………………………………………….……….

Country……………………………..

Phone num­ber: ………………………………            Stamp:

Fax num­ber:                 ………………………………

E-mail address: ………………………………

Natio­nal iden­ti­fi­ca­tion number:   ………………

The Under­sig­ned Phy­si­cian dec­la­res that:

1/ His/her patient (Name and Fore­name of the Patient:………………………………………) can­not be trea­ted ade­qua­tely with the pro­ducts currently avai­la­ble in the country and that for the treat­ment of his/her patient, the pro­duct (Men­tion deno­mi­na­tion, form, dosage and all rele­vant infor­ma­tion rele­vant for the pharmacist)

………………………………………………………………………………………………….…………………………………………………………………………………………………..

is neces­sary for a period of …………….. ………………(Men­tion period), with a poso­logy of

……………………………………………………………………………………………….….(Men­tion posology)

2/ He/she is aware that currently, in the con­cer­ned country, no Mar­ket Autho­ri­za­tion is gran­ted to this pro­duct and that at this stage, the pro­duct did not pass through qua­lity, effi­cacy and safety tests and that he/she did explain this situa­tion to the patient or representative(s) of the patient*.

* Please note that the pro­duct THYROID exists for a very long time now in Canada where it demons­tra­ted all evi­dence of qua­lity, effi­cacy and safety and obtai­ned a Mar­ket Autho­ri­za­tion.

3/ He/she will inform imme­dia­tely, without men­tio­ning the name of the con­cer­ned patient in order to pro­tect his/her pri­vate life, the Phar­ma­co­vi­gi­lance Cen­ter of the country where the pro­duct has to be deli­ve­red, in case of all unde­si­ra­ble side-effect (obviously lin­ked to the pro­duct here deli­ve­red) occu­rring during the treatment.

Date and sig­na­ture of the Physician,

………………………………………

……………………………………

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