Registration of the meeting of Aspen's representative with representatives of MZ SR, on 20.08.2015 at 12 noon at MZ SR

For MZ SR:

• director-General Department of Pharmacy and Drug Policy MUDr. Adam Hlôška
• director of the Department of Classification, Pricing and Drug Policy PharmDr. Rastislav Pullmann
• officer of the Department of Classification, Pricing and Drug Policy of MVDr. Erika Hanzelyová

For Aspen:

- Director General of the Company RNDr. Iva Váchová

The meeting was held at the initiative of MZ SR addressed to the company Aspen for the provision of processed data concerning Fraxiparine and Fragiparine forte and subsequent company request Aspen about working meeting.

The meeting was opened by the Director General of the Department of Pharmacy and Drug Policy Dr. Adam Hlôška.

For MZ SR:

MZ SR requested Aspen to process data concerning imports all categorised products of Fraxiparine and Fraxiparine forte Slovakia for the period 2014 and 2015 after each month.

MZ SR compared import data of the quantities of the products in question with data of their consumption according to NCZI data. These data show that Slovakia the quantities of the products in question imported are sufficient or higher. However, distribution companies of MZ SR confirmed that demand for these medicines in pharmacies are much higher. Patients who have trouble getting these drugs. MZ SR wonders how in this respect to be continued by the marketing authorisation holder to ensure sufficient quantities of medicinal products for Slovak patients.

For Aspen:

As rightly stated MZ SR, the company Aspen ensures the import of medicines Fragiparine and Fragiparine forte on the Slovak market in quantities not only cover the real consumption of both of these drugs by Slovak patients, but which even exceeds this real consumption.

Company objective Aspen has always been and currently is to ensure sufficient availability of authorised medicinal products imported into the Slovak market for Slovak patients. Unfortunately, Aspen does not know and does not a real possibility to influence all external factors that may affect availability of authorised medicines on the Slovak market. Such an important a factor significantly affecting the availability of registered medicinal products Aspen on the market is also their reexport.

Since Aspen has been shown to have imported it into the territory Slovak Republic in quantities sufficient to cover their consumption By Slovak patients, Aspen makes it possible to point out for a manifest failure to comply with the notification obligations imposed by the Act on medicinal products persons who export these medicines outside the territory of Slovakia Republic. Aspen therefore proposes to adopt such measures from parties of the competent national authorities, including MZ SR, to ensure that medicines imported on the Slovak market in quantities sufficient for coverage of real consumption by Slovak patients, not from Slovak territory the Republics exported in breach of applicable law, if the following drug shortages on the market.

For MZ SR:

Slovakia is part of the EU and free movement of goods applies here. SCHOOL can prohibit the export of medicinal products, only in accordance with current legislation of the Slovak Republic and EU. MZ SR is mandatory fully comply with legislation in this area and use all available the possibility of ensuring the availability of medicinal products. Compliance with the law No 363/2011 Z.z. on the scope and conditions of reimbursement of medicines, medical aids and dietetic foods based on public health insurance; and on the amendment of certain laws pursuant to Paragraph 97 (1) (a). (a) the administrative offence is committed by the holder of the marketing authorisation if the medicinal product has not been available on the market in sufficient quantities for 60 consecutive days pursuant to § 9 and until the date on which the Ministry became aware of that fact, the marketing authorisation holder has not applied for the withdrawal of the medicinal product from the list categorized medicinal products or an increase in the official price of the medicinal product, if applicable a medicinal product for which the conditions of Paragraph 19 (6) are met.

For Aspen:

Aspen considers that the primary purpose of manufacturing and distribution of medicines is their use for the purpose for which medicinal products are intended primarily to be used, i.e. for treatment of patients' diseases. Only when this primary purpose is filled with drugs may also serve secondary purposes for other commercial purposes.

In this spirit, it is therefore necessary to interpret Aspen also Article 9 of Law No 363/2011 Coll. on the availability of medicinal products the market in sufficient quantity to cover their estimated monthly consumption. However, the consumption of medicinal products in this case certainly cannot be understood as being outside the territory of the Slovak Republic, i.e. their use for commercial purposes. Drug consumption is exclusively used by patients to treat their disease. The correctness of the conclusion in question is also underlined by the fact that The legislator explicitly addresses the non-availability of medicinal products as they may be exports outside the territory of the Slovak Republic by other law (§19a of Act No. 362/2011 Coll. on medicinal products and medical devices) whose compliance and the control is to be ensured by the State through the competent authorities (SECTIONs).

As Aspen understands the requirement of MZ SR regarding the urgency of the need delivery of higher volume of medicines Fraxiparine and Fraxiparine forte in Slovak market, make every effort to ensure at least a transitional period the supply of higher volumes of the medicinal products in question to the Slovak market. No matter However, aspen maintains its view that it is supplied by Aspen. the quantities of Fraxiparine and Fragiparine forte on the Slovak market meet all requirements laid down by generally binding legislation.

The sitting was closed by the Director-General of the Department of Pharmacy and Drug Policy Dr. Adam Hlôška.