State Institute for Drug Control	      phone: +420 272 185 111	          e-mail: posta@sukl.cz
	Šrobárova 48, 100 41 Praha 10	      fax: +420 271 732 377	          web: www.sukl.cz
	Czech Republic	

NOTIFICATION OF THE COMMENCEMENT OF DISTRIBUTION ACTIVITIES WITHIN THE TERRITORY OF THE CZECH REPUBLIC BASED UPON DISTRIBUTION AUTHORISATION FOR MEDICINAL PRODUCTS ISSUED BY ANOTHER EU MEMBER STATE

The obligation to notify in advance pursuant to Section 75 par. 4 of Act No 378/2007 Coll., on Pharmaceuticals, as amended

Name - distributor’s trade company; name and surname for a natural person
		
Distributor's address – country and registered office address for legal persons; address of business premises for natural persons 
		
Distributor's statutory representative, in case of a legal person – name, surname		
Identification company number as in the official registry		
Distributor's contact details – contact person, phone, fax, e-mail

Date of distribution commencement in the CR		
Competent authority of the other Member State, which has issued the distribution authorisation – name, address
		
Type and scope of distribution
		
Addresses of all distribution sites from which distribution will be performed (if there is insufficient space, please provide the data on a separate sheet)

Annexes to the application – please check annexes submitted together with this form	
a)	Proof of distribution authorisation issued by the relevant state as currently valid (with Czech or English translation)		
b)	others – please specify		

I hereby declare that the data in the form and attached documentation are true and correct and that I am aware of all the obligations imposed on me by Section 77 of the Act on Pharmaceuticals, in particular of the obligation to report regularly to the State Institute for Drug Control data concerning the volume of medicinal products distributed to healthcare facilities incl. pharmacies in line with the SUKL Guideline. 

Date:		Signature (signature of the statutory representative for legal persons)
		Name, surname:

	State Institute for Drug Control	      phone: +420 272 185 111	          e-mail: posta@sukl.cz
	Šrobárova 48, 100 41 Praha 10	      fax: +420 271 732 377	          web: www.sukl.cz
	Czech Republic	

NOTIFICATION OF A CHANGE IN INFORMATION ON THE DISTRIBUTOR PERFORMING DISTRIBUTION ACTIVITIES WITHIN THE TERRITORY OF THE CZECH REPUBLIC BASED UPON DISTRIBUTION AUTHORISATION FOR MEDICINAL PRODUCTS ISSUED BY ANOTHER EU MEMBER STATE

Original notification submitted on .......................

The obligation to provide the data necessary for co-operation between the State Institute for Drug Control and the distributor and other information on the scope of distribution and location of distribution stores pursuant to Section 75 par. 4 of Act No 378/2007 Coll., on Pharmaceuticals, as amended

Name - distributor’s trade company; name and surname for a natural person
		
Distributor's address – country and registered office address for legal persons; address of business premises for natural persons 
		
Identification company number as in the official registry		
Distributor's contact details – contact person, phone, fax, e-mail

Changes to originally notified data - please list all proposed changes, in the case of a change in the distribution authorisation issued by the Competent Authority, annex the copy of the authorisation (if there is insufficient space, please provide the data on a separate sheet)

	Present	Proposed	
			
Annexes to the application – please check annexes submitted together with this form	
a)	Proof of distribution authorisation issued by the relevant state as currently valid (with Czech or English translation)		
b)	others – please specify		

I hereby declare that the data in the form and attached documentation are true and correct.

Date:		Signature (signature of a statutory representative for legal persons)
		Name, surname: